Trial Outcomes & Findings for A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients (NCT NCT00234832)

NCT ID: NCT00234832

Last Updated: 2010-05-11

Results Overview

For each subject, POE status (with/without an event) and time to first occurrence of a POE using time-to-event analysis were evaluated. All POE confirmed by an independent adjudication committee were included in the analysis.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 10777 participants
• Primary outcome timeframe: From randomization up to 6 years
• Results posted on: 2010-05-11

Participant Flow

Of the 10777 subjects enrolled into the study, 33 were not treated with Lead-in Period sibutramine. Of the 10744 subjects who took at least 1 dose of Lead-in Period sibutramine, 939 were not randomized. One of the remaining 9805 subjects was not dispensed randomized study drug and was not included in the intent-to-treat population (N = 9804).

Participant milestones

Measure	Randomized Sibutramine Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.	Randomized Placebo Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
Overall Study STARTED	4906	4898
Overall Study COMPLETED	3890	3902
Overall Study NOT COMPLETED	1016	996

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients

Baseline characteristics by cohort

Measure	Randomized Sibutramine n=4906 Participants Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.	Randomized Placebo n=4898 Participants Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.	Total n=9804 Participants Total of all reporting groups
Age, Categorical Between 18 and 65 years	3040 Participants n=5 Participants	2997 Participants n=7 Participants	6037 Participants n=5 Participants
Age, Categorical >=65 years	1866 Participants n=5 Participants	1901 Participants n=7 Participants	3767 Participants n=5 Participants
Age Continuous	63.2 years STANDARD_DEVIATION 6.09 • n=5 Participants	63.3 years STANDARD_DEVIATION 6.15 • n=7 Participants	63.2 years STANDARD_DEVIATION 6.12 • n=5 Participants
Sex: Female, Male Female	2099 Participants n=5 Participants	2055 Participants n=7 Participants	4154 Participants n=5 Participants
Sex: Female, Male Male	2807 Participants n=5 Participants	2843 Participants n=7 Participants	5650 Participants n=5 Participants
Region of Enrollment Europe	4160 participants n=5 Participants	4150 participants n=7 Participants	8310 participants n=5 Participants
Region of Enrollment Australia	384 participants n=5 Participants	385 participants n=7 Participants	769 participants n=5 Participants
Region of Enrollment Brazil	233 participants n=5 Participants	234 participants n=7 Participants	467 participants n=5 Participants
Region of Enrollment Mexico	129 participants n=5 Participants	129 participants n=7 Participants	258 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Cardiovascular (CV) risk group status DM only	1207 Participants n=5 Participants	1178 Participants n=7 Participants	2385 Participants n=5 Participants
Cardiovascular (CV) risk group status CV only	759 Participants n=5 Participants	793 Participants n=7 Participants	1552 Participants n=5 Participants
Cardiovascular (CV) risk group status CV + DM	2906 Participants n=5 Participants	2901 Participants n=7 Participants	5807 Participants n=5 Participants
Cardiovascular (CV) risk group status Unknown CV risk group status	34 Participants n=5 Participants	26 Participants n=7 Participants	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization up to 6 years

Population: Analysis based on intent-to-treat (ITT) population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized. Subjects were also categorized into 1 of 3 prespecified CV risk groups: diabetes mellitus (DM) only, CV only, and CV + DM.

For each subject, POE status (with/without an event) and time to first occurrence of a POE using time-to-event analysis were evaluated. All POE confirmed by an independent adjudication committee were included in the analysis.

Outcome measures

Measure	Randomized Sibutramine n=4906 Participants Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.	Randomized Placebo n=4898 Participants Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.	DM Only Randomized to Sibutramine n=1207 Participants Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	DM Only Randomized to Placebo n=1178 Participants Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.	CV Only Randomized to Sibutramine n=759 Participants Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	CV Only Randomized to Placebo n=793 Participants Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.	CV + DM Randomized to Sibutramine n=2906 Participants Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	CV + DM Randomized to Placebo n=2901 Participants Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death) Intent-to-treat population	561 Participants	490 Participants	79 Participants	77 Participants	77 Participants	66 Participants	403 Participants	346 Participants

SECONDARY outcome

Timeframe: From randomization up to 6 years

Population: Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.

For each subject who died, the time to death was evaluated using time-to-event analysis.

Outcome measures

Measure	Randomized Sibutramine n=4906 Participants Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.	Randomized Placebo n=4898 Participants Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.	DM Only Randomized to Sibutramine Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	DM Only Randomized to Placebo Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.	CV Only Randomized to Sibutramine Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	CV Only Randomized to Placebo Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.	CV + DM Randomized to Sibutramine Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	CV + DM Randomized to Placebo Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
Risk of Death From Any Cause (All-cause Mortality)	418 Participants	404 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From randomization up to 6 years

Population: Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.

This outcome includes nonfatal MI, nonfatal stroke, resuscitated cardiac arrest, CV death (including events such as fatal MI and fatal stroke), and any of the following revascularization procedures: percutaneous transluminal coronary angioplasty, coronary artery bypass graft, coronary artery stent placement, cardiac transplant, peripheral vascular bypass or angioplasty, and carotid endarterectomy. For each subject, the POE or revascularization status (yes/no) and time to first occurrence of an event using time-to-event analysis were evaluated.

Outcome measures

Measure	Randomized Sibutramine n=4906 Participants Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.	Randomized Placebo n=4898 Participants Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.	DM Only Randomized to Sibutramine Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	DM Only Randomized to Placebo Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.	CV Only Randomized to Sibutramine Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	CV Only Randomized to Placebo Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.	CV + DM Randomized to Sibutramine Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	CV + DM Randomized to Placebo Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
Risk of Experiencing a POE or a Revascularization Procedure	927 Participants	856 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From randomization up to 6 years

Population: Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.

For each subject, the first occurrence of a nonfatal MI included in the POE was evaluated using time-to-event analysis.

Outcome measures

Measure	Randomized Sibutramine n=4906 Participants Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.	Randomized Placebo n=4898 Participants Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.	DM Only Randomized to Sibutramine Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	DM Only Randomized to Placebo Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.	CV Only Randomized to Sibutramine Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	CV Only Randomized to Placebo Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.	CV + DM Randomized to Sibutramine Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	CV + DM Randomized to Placebo Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
Risk of Experiencing a Nonfatal MI Included in the POE	200 Participants	159 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From randomization up to 6 years

Population: Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.

For each subject, the time to first occurrence of a nonfatal stroke included in the POE was evaluated using time-to-event analysis.

Outcome measures

Measure	Randomized Sibutramine n=4906 Participants Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.	Randomized Placebo n=4898 Participants Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.	DM Only Randomized to Sibutramine Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	DM Only Randomized to Placebo Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.	CV Only Randomized to Sibutramine Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	CV Only Randomized to Placebo Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.	CV + DM Randomized to Sibutramine Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	CV + DM Randomized to Placebo Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
Risk of Experiencing a Nonfatal Stroke Included in the POE	127 Participants	95 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From randomization up to 6 years

Population: Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.

For each subject, the time to first occurrence of a resuscitated cardiac arrest included in the POE was evaluated using time-to-event analysis.

Outcome measures

Measure	Randomized Sibutramine n=4906 Participants Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.	Randomized Placebo n=4898 Participants Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.	DM Only Randomized to Sibutramine Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	DM Only Randomized to Placebo Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.	CV Only Randomized to Sibutramine Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	CV Only Randomized to Placebo Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.	CV + DM Randomized to Sibutramine Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	CV + DM Randomized to Placebo Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE	11 Participants	7 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From randomization up to 6 years

Population: Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.

For each subject, the time to cardiovascular death included in the POE was evaluated using time-to-event analysis.

Outcome measures

Measure	Randomized Sibutramine n=4906 Participants Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.	Randomized Placebo n=4898 Participants Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.	DM Only Randomized to Sibutramine Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	DM Only Randomized to Placebo Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.	CV Only Randomized to Sibutramine Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	CV Only Randomized to Placebo Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.	CV + DM Randomized to Sibutramine Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.	CV + DM Randomized to Placebo Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
Risk of Experiencing Cardiovascular Death Included in the POE	223 Participants	229 Participants	—	—	—	—	—	—

Adverse Events

Lead-in Period Sibutramine

Serious events: 425 serious events

Other events: 0 other events

Deaths: 0 deaths

Randomized Sibutramine

Serious events: 2063 serious events

Other events: 0 other events

Deaths: 0 deaths

Randomized Placebo

Serious events: 1977 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lead-in Period Sibutramine n=10744 participants at risk Subjects who received sibutramine 10 mg QD plus standard care for weight management during a 6-week Lead-in Period.	Randomized Sibutramine n=4904 participants at risk Subjects who successfully completed a 6-week Lead-in Period and who were randomized to receive sibutramine plus standard care for weight management during the Treatment Period of the Randomization Phase, and if sibutramine was prematurely discontinued, they received standard care for weight management during the Follow-up Period of the Randomization Phase.	Randomized Placebo n=4881 participants at risk Subjects who successfully completed a 6-week Lead-in Period and who were randomized to receive placebo plus standard care for weight management during the Treatment Period of the Randomizaiton Phase, and if placebo was prematurely discontinued, they received standard care for weight management during the Follow-up Period of the Randomization Phase.
Blood and lymphatic system disorders Normochromic normocytic anemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Anemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.39% 19/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.23% 11/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Bicytopenia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Hemolytic anemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Hemorrhagic anemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Hemorrhagic disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Hypersplenism	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Hypochromic anemia	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Hypoprothrombinanemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Iron deficiency anemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Lymphatic obstruction	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Lymphocytosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Microcytic anemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Neutropenia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Acute coronary syndrome	0.06% 6/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.51% 25/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.53% 26/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Acute left ventricular failure	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Acute myocardial infarction	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	1.8% 87/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	1.8% 87/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Adams-Stokes syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Angina pectoris	0.20% 21/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	2.3% 111/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	2.7% 133/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Angina unstable	0.21% 23/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	2.5% 122/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	2.1% 104/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Aortic valve disease	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Aortic valve disease mixed	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Aortic valve incompetence	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Aortic valve stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.18% 9/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Arrhythmia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Atrial fibrillation	0.19% 20/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	2.3% 115/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	2.8% 135/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Atrial flutter	0.04% 4/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.43% 21/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.59% 29/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Atrial tachycardia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Atrial thrombosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Atrioventricular block	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Atrioventricular block complete	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.33% 16/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Atrioventricular block first degree	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Atrioventricular block second degree	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.33% 16/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Bradyarrhythmia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Bradycardia	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Bundle branch block right	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Cardiac aneurysm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Cardiac arrest	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.49% 24/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.29% 14/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Cardiac asthma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Cardiac disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Cardiac failure	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	1.7% 82/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	1.6% 80/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Cardiac failure acute	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.18% 9/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Cardiac failure chronic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Cardiac failure congestive	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	1.1% 53/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.84% 41/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Cardiac tamponade	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Cardio-respiratory arrest	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Cardiogenic shock	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Cardiomyopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Cardiopulmonary failure	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Cardiovascular insufficiency	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Chronic right ventricular failure	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Conduction disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Congestive cardiomyopathy	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Cor pulmonale chronic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Coronary artery disease	0.14% 15/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	2.8% 135/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	2.4% 118/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Coronary artery dissection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Coronary artery insufficiency	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Coronary artery occlusion	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Coronary artery stenosis	0.04% 4/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	1.5% 76/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	1.5% 74/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Coronary artery thrombosis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Diastolic dysfunction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Extrasystoles	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Hypertensive cardiomyopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Hypertensive heart disease	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Intracardiac thrombus	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Ischemic cardiomyopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.20% 10/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.27% 13/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Left ventricular dysfunction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Left ventricular failure	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.20% 10/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.33% 16/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Left ventricular hypertrophy	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Mitral valve incompetence	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Mitral valve stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Myocardial infarction	0.10% 11/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	1.8% 87/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	1.6% 80/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Myocardial ischemia	0.05% 5/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	1.2% 57/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.74% 36/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Nodal arrhythmia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Palpitations	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Pericardial effusion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Pericarditis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Postinfarction angina	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Prinzmetal angina	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Right ventricular failure	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Sick sinus syndrome	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.22% 11/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.25% 12/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Silent myocardial infarction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Sinoatrial block	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Sinus arrhythmia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Sinus bradycardia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Sinus tachycardia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Subendocardial ischemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Supraventricular tachyarrhythmia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Supraventricular tachycardia	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.24% 12/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Tachyarrhythmia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Tachycardia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Torsade de pointes	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Trifascicular block	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Ventricular arrhythmia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Ventricular extrasystoles	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Ventricular failure	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Ventricular fibrillation	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Ventricular tachyarrhythmia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Cardiac disorders Ventricular tachycardia	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.51% 25/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.37% 18/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Congenital, familial and genetic disorders Congenital cystic kidney disease	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Congenital, familial and genetic disorders Congenital spondylolithesis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Congenital, familial and genetic disorders Dysplastic naevus syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Congenital, familial and genetic disorders Gastrointestinal angiodysplasia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Congenital, familial and genetic disorders Gastrointestinal angiodysplasia hemorrhagic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Congenital, familial and genetic disorders Hydrocele	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Congenital, familial and genetic disorders Phimosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Ear and labyrinth disorders Acute vestibular syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Ear and labyrinth disorders Aural polyp	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Ear and labyrinth disorders Hearing impaired	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Ear and labyrinth disorders Hypoacusis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Ear and labyrinth disorders Neurosensory hypoacusis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Ear and labyrinth disorders Vertigo	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Ear and labyrinth disorders Vertigo positional	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Endocrine disorders Autoimmune thyroiditis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Endocrine disorders Goiter	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Endocrine disorders Hyperparathyroidism	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Endocrine disorders Hyperparathyroidism primary	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Endocrine disorders Hyperthyroidism	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Endocrine disorders Hypothyroidism	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Endocrine disorders Myxedema	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Endocrine disorders Toxic nodular goiter	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Amaurosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Angle closure glaucoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Aphakia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Cataract	0.04% 4/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.67% 33/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.59% 29/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Cataract diabetic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Cataract nuclear	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Cataract subcapsular	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Diabetic retinopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Diplopia	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Extraocular muscle paresis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Eye hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Eye pain	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Glaucoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Iris bombe	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Keratitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Lens dislocation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Macular hole	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Macular edema	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Maculopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Ocular myasthenia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Ocular vascular disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Open-angle glaucoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Optic ischemic neuropathy	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Punctate keratitis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Retinal artery occlusion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Retinal detachment	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.20% 10/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Retinal hemorrhage	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Retinal vein occlusion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Retinal vein thrombosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Strabismus	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Synchysis scintillans	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Ulcerative keratitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Uveitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Visual impairment	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Vitreous detachment	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Vitreous disorder	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Eye disorders Vitreous hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Abdominal distension	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Abdominal hernia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Abdominal hernia obstructive	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Abdominal mass	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Abdominal pain	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.18% 9/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Abdominal strangulated hernia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Anal fissure	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Anal fistula	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Anal stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Anal ulcer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Barrett's esophagus	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Cecitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Change of bowel habit	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Celiac artery stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Colitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Colitis ischemic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Colonic polyp	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.20% 10/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Constipation	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Diabetic gastroparesis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Diarrhea	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Diarrhea hemorrhagic	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Diverticulitis intestinal hemorrhagic	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Diverticulum	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Diverticulum intestinal hemorrhagic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Duodenal ulcer	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Duodenal ulcer hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.24% 12/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Duodenal ulcer perforation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Duodenitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Dyspepsia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Enteritis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Enterocolitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Erosive esophagitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Fecal incontinence	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Fecaloma	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Food poisoning	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastric mucosal lesion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastric perforation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastric polyps	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastric ulcer	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastric ulcer hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.18% 9/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.18% 9/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastritis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastritis atrophic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastritis erosive	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastritis hemorrhagic	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastroduodenitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastrointestinal hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastrointestinal inflammation	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastrointestinal ulcer hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastroesophageal sphincter insufficiency	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gastroesophagitis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Gingival pain	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Hematochezia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Hemorrhagic erosive gastritis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Hemorrhoids	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Hernial eventration	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Hiatus hernia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Ileitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Ileus	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Ileus paralytic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Inguinal hernia	0.04% 4/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.27% 13/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.37% 18/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Intestinal ischemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Intra-abdominal hematoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Large intestine perforation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Mechanical ileus	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Melena	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Melanosis coli	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Mesenteric artery stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Mesenteric artery thrombosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Mesenteric occlusion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Nausea	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Esophageal stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Esophageal ulcer hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Esophagitis	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Esophagitis ulcerative	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Pancreatitis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.29% 14/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Pancreatitis necrotizing	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Papilla of Vater stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Peptic ulcer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Peptic ulcer hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Periodontal disease	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Peritoneal adhesions	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Peritoneal hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Peritonitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Proctitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Rectal hemorrhage	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Rectal perforation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Rectal polyp	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Rectal prolapse	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Reflux esophagitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Retroperitoneal fibrosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Retroperitoneal hematoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Small intestinal hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Subileus	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Tongue hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Tooth disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Tooth loss	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Umbilical hernia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.24% 12/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.18% 9/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Umbilical hernia, obstructive	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Varices esophageal	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Gastrointestinal disorders Vomiting	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Abasia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Adhesion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Adverse drug reaction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Asthenia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Catheter-related complication	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Chest discomfort	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Chest pain	0.05% 5/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.45% 22/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.37% 18/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Chills	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Cyst	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Death	0.16% 17/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.51% 25/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.37% 18/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Drug intolerance	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Dysplasia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Fatigue	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Foaming at mouth	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders General physical health deterioration	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Hernia obstructive	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Impaired healing	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Implant expulsion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Implant site fibrosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Implant site inflammation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Inflammation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Malaise	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Mechanical complication of implant	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Metaplasia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Multi-organ failure	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Necrosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Non-cardiac chest pain	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.39% 19/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.31% 15/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Pain	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Peripheral edema	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Pyrexia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Sudden cardiac death	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.22% 11/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Sudden death	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.39% 19/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.53% 26/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Swelling	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Bile duct stone	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Biliary cirrhosis primary	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Biliary colic	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Cholangitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Cholangitis acute	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Cholecystitis	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Cholelithiasis	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.53% 26/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.51% 25/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Cirrhosis alcoholic	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Gallbladder cholesterolosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Gallbladder disorder	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Gallbladder obstruction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Gallbladder perforation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
General disorders Hepatic lesion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Hepatic mass	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Hepatitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Hepatitis acute	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Hepatorenal failure	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Liver disorder	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Hepatobiliary disorders Liver injury	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Immune system disorders Anaphylactic reaction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Immune system disorders Anaphylactic shock	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Immune system disorders Hypersensitivity	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Abdominal abscess	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Abscess limb	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Abscess neck	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Abscess oral	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Acarodermatitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Anal abscess	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Appendicitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Appendicitis perforated	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Arteriosclerotic gangrene	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Arthritis bacterial	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Arthritis infective	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Bacterial infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Bacterial pyelonephritis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Biliary sepsis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Bronchiectasis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Bronchitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.27% 13/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.31% 15/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Bronchitis bacterial	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Bronchitis viral	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Bronchopneumonia	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.29% 14/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.35% 17/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Bronchopulmonary aspergillosis allergic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Campylobacter intestinal infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Catheter-site infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Cellulitis	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.39% 19/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.35% 17/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Cellulitis staphylococcal	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Central line infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Cholecystitis infective	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Chronic sinusitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Clostridium difficile colitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Cystitis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Dengue fever	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Device-related infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Diabetic foot infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Diabetic gangrene	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Diarrhea infectious	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Diverticulitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Endocarditis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Endocarditis bacterial	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Endocarditis staphylococcal	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Endophthalmitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Entereocolitis viral	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Erysipelas	0.05% 5/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.47% 23/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.29% 14/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Escherichia sepsis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Escherichia urinary tract infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Eye infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Furuncle	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Gallbladder empyema	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Gangrene	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Gastroenteritis	0.04% 4/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.27% 13/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.31% 15/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Gastroenteritis bacterial	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Gastroenteritis clostridial	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Gastroenteritis salmonella	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Gastroenteritis viral	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Gingival abscess	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Graft infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Groin abscess	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Hematoma infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Helicobacter infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Hepatitis A	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Hepatitis B	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Hepatitis C	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Hepatitis viral	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Herpes zoster	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Herpes zoster ophthalmic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Infected sebaceous cyst	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Infected skin ulcer	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.25% 12/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Infective tenosynovitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Influenza	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Infusion site infection	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Intervertebral discitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Kidney infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Klebsiella sepsis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Labyrinthitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Laryngitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Liver abscess	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Lobar pneumonia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.27% 13/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Localized infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Lower respiratory tract infection	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.20% 10/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Lung abscess	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Lung infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Lung infection pseudomonal	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Lyme disease	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Lymph node tuberculosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Mastitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Mediastinitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Meningococcal sepsis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Nasopharyngitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Neuroborreliosis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Oral candidiasis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Orchitis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Osteomyelitis	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.27% 13/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Otitis media acute	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Otitis media chronic	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Paronychia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Parotitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Perihepatic abscess	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Perineal abscess	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Perirectal abscess	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Peritonsillar abscess	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Peritonsillitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Pharyngeal abscess	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Pharyngitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Pleurisy viral	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Pneumococcal sepsis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Pneumonia	0.05% 5/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	1.0% 51/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	1.2% 59/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Pneumonia bacterial	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Pneumonia escherichia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Pneumonia legionella	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Pneumonia pneumococcal	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Post-procedural cellulitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Post-procedural infection	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Postoperative abscess	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Postoperative wound infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Prostatic abscess	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Pulmonary sepsis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Pulmonary tuberculosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Pyelocystitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Pyelonephritis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Pyelonephritis acute	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Pyothorax	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Rash pustular	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Rectal abscess	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Respiratory tract infection	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Salmonella sepsis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Salmonellosis	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Sepsis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.22% 11/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.27% 13/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Septic shock	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.18% 9/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Sinusitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Sinusitis bacterial	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Skin bacterial infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Skin infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Staphylococcal infection	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Staphylococcal sepsis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Sternitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Streptococcal sepsis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Subacute endocarditis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Subcutaneous abscess	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Sweat gland infection	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Testicular abscess	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Tonsillitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Tooth abscess	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Toxic shock syndrome	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Tracheitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Tracheobronchitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Tuberculosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Upper respiratory tract infection	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Urinary tract infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.33% 16/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.47% 23/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Urinary tract infection bacterial	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Urosepsis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Vestibular neuronitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Viral infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Viral labyrinthitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Visceral leishmaniasis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Vulval cellulitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Wound abscess	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Wound infection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Infections and infestations Wound infection staphylococcal	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Accidental needle stick	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Anastomotic complication	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Ankle fracture	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Arterial restenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Ateriovenous fistula thrombosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Asbestosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Bladder injury	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Brachial plexus injury	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Brain contusion	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Cardiac pacemaker malfunction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Cerebral hemorrhage traumatic	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Cerebral hyperperfusion syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Concussion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Confusion postoperative	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Contusion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Coronary artery restenosis	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.20% 10/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.23% 11/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Coronary bypass thrombosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Device breakage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Device dislocation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Device failure	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Device lead damage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Device malfunction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Device occlusion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Dislocation of joint prosthesis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Drug administration error	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Drug dispensing error	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Drug toxicity	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Eye injury	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Face injury	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Fall	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Femoral neck fracture	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Foreign body trauma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Fracture displacement	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Gastroenteritis radiation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Graft thrombosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Head injury	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Iatrogenic injury	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Implantable defibrillator malfunction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications In-stent arterial restenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications In-stent coronary artery restenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Inappropriate device stimulation of tissue	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Incision site complication	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Incisional hernia, obstructive	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Injury	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Intervertebral disc injury	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Joint dislocation	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Joint injury	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Keratorhexis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Lead dislodgement	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Ligament rupture	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Limb injury	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Medical device complication	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Medical device pain	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Meniscus lesion	0.04% 4/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Multiple injuries	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Muscle injury	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Operative hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Overdose	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Pelvic fracture	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Periprosthetic osteolysis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Post lumbar puncture syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Post procedural complication	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Post procedural fistula	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Post procedural hematoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Post procedural hemorrhage	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Post procedural myocardial infarction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Post procedural stroke	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Post procedural swelling	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Postmastectomy lymphedema syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Postoperative adhesion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Postoperative hernia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Postoperative thrombosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Postoperative wound complication	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Postpericardiotomy syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Procedural hypotension	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Seroma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Skull fractured base	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Stent occlusion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Subcutaneous hematoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Subdural hematoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.20% 10/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Therapeutic agent toxicity	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Thrombosis in device	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Tongue injury	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Traumatic amputation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Traumatic brain injury	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Traumatic fracture	0.04% 4/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.27% 13/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.37% 18/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Traumatic hematoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Traumatic lung injury	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Traumatic shock	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Traumatic ulcer	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Ureteric anastomosis complication	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Urinary retention postoperative	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Vaccination complication	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Vascular graft complication	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Vascular graft occlusion	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Wound	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Wound evisceration	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Wound hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Wound necrosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Angiogram	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Anticoagulation drug level above therapeutic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Arteriogram coronary	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Arteriogram renal	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Blood creatinine increased	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Blood glucose increased	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Blood iron decreased	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Blood potassium decreased	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Body temperature increased	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Cardiac stress test abnormal	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Catheterization cardiac	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Coagulation time prolonged	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Colonoscopy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Diagnostic procedure	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Ejection fraction decreased	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Hemoglobin decreased	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Heart rate irregular	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Hepatic enzyme increased	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations International normalized ratio increased	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Investigation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Laboratory test abnormal	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Medical observation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Platelet count decreased	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Renal function test abnormal	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Scan myocardial perfusion abnormal	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Urine output decreased	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Weight decreased	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations Weight increased	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Investigations X-ray abnormal	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Dehydration	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Diabetes mellitus	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.61% 30/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.57% 28/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.04% 4/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	1.4% 67/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	1.0% 50/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Diabetes with hyperosmolarity	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Diabetic foot	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.35% 17/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.31% 15/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Gout	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.27% 13/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Hyperkalemia	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Hyperphagia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Hypoglycemia	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.35% 17/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.31% 15/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Hypokalemia	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Hyponatremia	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Hypovolemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Insulin-requiring type 2 diabetes mellitus	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Metabolic disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Neuroglycopenia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Obesity	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Weight loss poor	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Adenomyosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.20% 10/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Arthrofibrosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.18% 9/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.27% 13/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Bunion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Cervical spinal stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Chrondopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Costochondritis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Exostosis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Facet joint syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Metabolism and nutrition disorders Fibromyalgia	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Foot deformity	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Gouty tophus	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Hand deformity	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.31% 15/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.31% 15/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Intervertebral disc space narrowing	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Joint contracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Knee deformity	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Ligament disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.18% 9/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.25% 12/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Monarthritis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Muscle hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.29% 14/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.23% 11/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Myalgia intercostal	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.08% 9/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	2.2% 107/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	1.8% 88/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Scleroderma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Senile ankylosing vertebral hyperostosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Spinal disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.25% 12/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Tendinous contracture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Tendon calcification	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Musculoskeletal and connective tissue disorders Trigger finger	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acoustic neuroma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Astrocytoma malignant	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basosquamous carcinoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign anorectal neoplasm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign colonic neoplasm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign renal neoplasm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder adenocarcinoma stage unspecified	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer stage 0, with cancer in situ	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer stage II	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer stage III	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.24% 12/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma recurrent	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage II	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage IV	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.41% 20/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.31% 15/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage II	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage III	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage IV	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast fibroma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchioalveolar carcinoma	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chloroma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.22% 11/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.20% 10/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage 0	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage III	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage I	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicle center lymphoma, follicular grade I, II, III	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gammopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Head and neck cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papilloma of breast	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna stage unspecified	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip neoplasm malignant stage unspecified	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage II	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.18% 9/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage unspecified	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of renal pelvis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of uterine adnexa	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant peritoneal neoplasm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma benign	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma malignant	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bladder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone marrow	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic bronchial carcinoma	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoma of the bladder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic uterine cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mycosis fungoides	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm of appendix	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm prostate	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurilemmoma malignant	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroectodermal neoplasm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma stage IV	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IV	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Esophageal carcinoma	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Esophageal squamous cell carcinoma metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oligodendroglioma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral papilloma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian granulosa-theca cell tumor	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancoast's tumor	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumor benign	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumor benign	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Porocarcinoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.53% 26/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.41% 20/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage I	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage II	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer stage III	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma stage I	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rhabdomyoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland adenoma	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal hemangioma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Superficial spreading melanoma stage IV	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Teratoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteric cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteric cancer metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer metastatic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Amnesia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Apallic syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Basal ganglia hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Basilar artery stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Brain injury	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Brain stem hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Brain stem infarction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Brain stem stroke	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Carotid arteriosclerosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Carotid artery occlusion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Carotid artery stenosis	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.61% 30/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.66% 32/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Carotid sinus syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Carpal tunnel syndrome	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.18% 9/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Central nervous system lesion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cerebellar infarction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cerebellar ischemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cerebellar syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cerebral artery embolism	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cerebral artery stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cerebral cyst	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cerebral hematoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cerebral hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cerebral infarction	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.31% 15/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.25% 12/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cerebral ischemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cerebral thrombosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cerebrovascular accident	0.07% 8/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.94% 46/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.90% 44/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cerebrovascular insufficiency	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cervical myelopathy	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cluster headache	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cognitive disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Coma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Complicated migraine	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Cubital tunnel syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Dementia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Dementia Alzheimer's type	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Diabetic encephalopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Diabetic neuropathy	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Dizziness	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Dysaesthesia	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Dysarthria	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Dysstasia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Embolic stroke	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Encephalopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Epidural lipomatosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Epilepsy	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Facial palsy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Facial paresis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Hemorrhage intracranial	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Hemorrhagic stroke	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Hemorrhagic transformation stroke	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Head titubation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Headache	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Hemiparesis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Hepatic encephalopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Hypoglycemic coma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Hypoxic encephalopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders IIIrd nerve paresis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Incoherent	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Intercostal neuralgia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Intracranial aneurysm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Intracranial hematoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Ischemic cerebral infarction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Ischemic stroke	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.86% 42/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.45% 22/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders IVth nerve paresis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Lacunar infarction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Lethargy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Loss of consciousness	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Lumbar radiculopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Meralgia paraesthetica	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Metabolic encephalopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Migraine	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Migraine with aura	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Myasthenia gravis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Myelitis transverse	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Myelopathy	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Nerve compression	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Neuralgia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Neuropathy peripheral	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Paraesthesia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Paralysis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Parkinson's disease	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Parkinsonism	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Polyneuropathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Post-herpetic neuralgia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Post-traumatic epilepsy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Presyncope	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Pseudoradicular syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Radial nerve palsy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Radicular pain	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Radicular syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Radiculopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Reversible ischemic neurological deficit	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Sciatica	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Somnolence	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Spinal claudication	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Spinal cord infarction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Spondylitic myelopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Subarachnoid hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Syncope	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.39% 19/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.43% 21/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Thalamic infarction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Transient global amnesia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Transient ischemic attack	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.69% 34/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.74% 36/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Tremor	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Trigeminal neuralgia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Vascular dementia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Vascular encephalopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Vertebral artery occlusion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Vertebral artery stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Vertebrobasilar insufficiency	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders Vertigo CNS origin	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders VIIth nerve paralysis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Nervous system disorders VIth nerve paralysis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Abnormal behavior	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Acute psychosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Adjustment disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Alcoholism	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Anxiety	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Bereavement reaction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Completed suicide	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Confusional state	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Conversion disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Delirium	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Depression	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.20% 10/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Hallucination, visual	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Hypochondriasis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Mood disorder due to a general medical condition	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Personality disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Psychotic disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Schizoaffective disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Schizophreniform disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Psychiatric disorders Suicide attempt	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Acute prerenal failure	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Azotemia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Bladder neck obstruction	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Bladder neck sclerosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Bladder obstruction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Bladder prolapse	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Bladder stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Bladder tamponade	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Calculus bladder	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Calculus ureteric	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Calculus urethral	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Calculus urinary	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Cystitis hemorrhagic	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Diabetic nephropathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Hematuria	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Hydronephrosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Nephrolithiasis	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.27% 13/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.23% 11/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Nephropathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Nephropathy toxic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Obstructive uropathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Pollakiuria	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Pyuria	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Renal artery arteriosclerosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Renal artery stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Renal artery thrombosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Renal colic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Renal cyst	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Renal disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Renal failure	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.35% 17/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.37% 18/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Renal failure acute	0.05% 5/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.37% 18/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.31% 15/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Renal failure chronic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.18% 9/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.23% 11/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Renal hypertension	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Renal impairment	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Stress urinary incontinence	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Ureteric obstruction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Ureteric stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Urethral caruncle	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Urethral hemorrhage	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Urethral meatus stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Urethral stenosis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Urinary bladder hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Urinary bladder polyp	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Urinary incontinence	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Urinary retention	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Renal and urinary disorders Urinary tract obstruction	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Acquired hydrocele	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Balanitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.07% 8/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.80% 39/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.61% 30/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Breast hyperplasia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Breast mass	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Cervical polyp	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Colpocele	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Cystocele	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Endometrial hypertrophy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Epididymal cyst	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Fibrocystic breast disease	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Genital prolapse	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Gynecomastia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Ovarian cyst	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Ovarian cyst torsion	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Posthitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Prostatism	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Prostatitis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Rectocele	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Scrotal cyst	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Testicular swelling	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Uterine polyp	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Uterine prolapse	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Uterovaginal prolapse	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Vaginal hemorrhage	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Reproductive system and breast disorders Vaginal prolapse	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Acute pulmonary edema	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.18% 9/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.24% 12/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Brain hypoxia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Bronchial dysplasia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Choking	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.06% 6/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.35% 17/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.43% 21/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Cough	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.37% 18/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.37% 18/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Dyspnea exertional	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Foreign body aspiration	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Hemothorax	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Laryngeal granuloma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Nasal septum perforation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Nasal turbinate hypertrophy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Organizing pneumonia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Pickwickian syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.31% 15/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.23% 11/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.31% 15/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.27% 13/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.18% 9/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Restrictive pulmonary disease	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Sleep apnea syndrome	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.29% 14/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.29% 14/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Snoring	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Upper airway obstruction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Respiratory, thoracic and mediastinal disorders Vocal cord inflammation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Diabetic bullosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Diabetic neuropathic ulcer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Diabetic ulcer	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Drug eruption	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Dry gangrene	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Eczema asteatotic	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Erythema nodosum	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Hidradenitis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Hirsutism	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Hypoaesthesia facial	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Leukocytoclastic vasculitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Lichen sclerosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Necrobiosis lipoidica diabeticorum	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Neuropathic ulcer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Psoriasis	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Pyoderma gangrenosum	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Scar pain	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Sebaceous hyperplasia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Social circumstances Activities of daily living impaired	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Social circumstances Family stress	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Social circumstances Social stay hospitalization	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Surgical and medical procedures Cardiac pacemaker battery replacement	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Surgical and medical procedures Cardiac pacemaker replacement	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Surgical and medical procedures Cholecystectomy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Surgical and medical procedures Coronary artery bypass	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Surgical and medical procedures Diabetes mellitus management	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Surgical and medical procedures Drug therapy changed	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Surgical and medical procedures Gastric banding	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Surgical and medical procedures Hip arthroplasty	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Surgical and medical procedures Hysterectomy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Surgical and medical procedures Implantable defibrillator replacement	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Surgical and medical procedures Intra-uterine contraceptive device removal	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Surgical and medical procedures Liposuction	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Surgical and medical procedures Medical device change	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Surgical and medical procedures Rehabilitation therapy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Surgical and medical procedures Therapeutic procedure	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Accelerated hypertension	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Angiodysplasia	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Aortic aneurysm	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.24% 12/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.27% 13/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Aortic aneurysm rupture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Aortic arteriosclerosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Aortic dilatation	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Aortic dissection	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Aortic rupture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Aortic stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.14% 7/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Arterial disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Arterial insufficiency	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Arterial occlusive disease	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Arterial rupture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Arterial stenosis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Arterial stenosis limb	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Arterial thrombosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Arterial thrombosis limb	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Arteriosclerosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Arteriosclerosis obliterans	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Arteriovenous fistula	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Arteritis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Circulatory collapse	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Deep vein thrombosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.27% 13/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.31% 15/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Diabetic microangiopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Diabetic vascular disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Embolism	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Exsanguination	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Extremity necrosis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Femoral arterial stenosis	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.37% 18/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.27% 13/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Femoral artery aneurysm	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Femoral artery occlusion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.20% 10/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Hematoma	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Hemorrhage	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Hot flush	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Hypertension	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.35% 17/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.53% 26/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Hypertensive crisis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.20% 10/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Hypertensive emergency	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Hypotension	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.10% 5/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Iliac artery occlusion	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Iliac artery stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Intermittent claudication	0.02% 2/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Lymphedema	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Macroangiopathy	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Orthostatic hypotension	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Pallor	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Peripheral arterial occlusive disease	0.03% 3/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	1.1% 52/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.80% 39/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Peripheral artery aneurysm	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.12% 6/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Peripheral embolism	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Peripheral ischemia	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.33% 16/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.29% 14/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Peripheral vascular disorder	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.24% 12/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.23% 11/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Phlebitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Phlebitis superficial	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Post thrombotic syndrome	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Shock	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Shock hemorrhagic	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.08% 4/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Subclavian artery stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Subclavian artery thrombosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Subclavian steal syndrome	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Subclavian vein thrombosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Temporal arteritis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Thromboangiitis obliterans	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Thrombophlebitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Thrombophlebitis superficial	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Thrombosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Varicophlebitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Varicose ulceration	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Varicose vein	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.29% 14/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Vascular rupture	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Vascular shunt	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Vascular stenosis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Vasculitis	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Vasculitis necrotizing	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Venous insufficiency	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.16% 8/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.06% 3/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Venous thrombosis	0.01% 1/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.00% 0/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.
Vascular disorders Venous thrombosis limb	0.00% 0/10744 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.02% 1/4904 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.	0.04% 2/4881 • Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose. SAEs confirmed to be outcome events are included. Lead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.

Other adverse events

Adverse event data not reported

Additional Information

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