Clinically significant new illness within 1 month before randomization that may affect the participant's ability to fulfill the study requirements or significantly confound the assessments
Participants who cannot swallow investigational products
Participants with T2DM who have hypoglycemia unawareness
Aortic regurgitation mild or greater
Mitral regurgitation moderate or greater
Mitral or aortic valve stenosis greater than mild (ie, aortic stenosis: jet >3.0 meters per second [m/s], mean gradient >25 millimeters of mercury [mmHg], and aortic valve area <1.5 centimeters squared [cm^2]; mitral stenosis: mean gradient >5 mmHg and mitral valve area <1.5 cm^2)
Systolic pulmonary artery pressure (SPAP) >40 mmHg (and/or tricuspid regurgitation [TR] jet velocity >2.9 m/s) In cases where an actual SPAP value is not measurable due to lack of adequate TR jet, the pulmonary flow acceleration time measured at the right ventricular outflow tract (RVOTAT) will be used to assess eligibility. Participants with a RVOTAT =100 milliseconds (msec) will be excluded, suggesting an elevated mean SPAP; eligibility for the those participants with RVOTAT between 100 and 120 msec will be determined based on combined assessment of the TR jet, septal motion, and right ventricular size.
Left ventricular ejection fraction <45%
Intracardiac mass, tumor, or thrombus
Evidence of congenital heart disease
Clinically significant pericardial effusion (eg, moderate or larger or with hemodynamic compromise)
Significant renal or hepatic disease as evidenced by a serum creatinine greater than 1.5× upper limit of normal (ULN), serum transaminases greater than 3× ULN, or total bilirubin greater than 1.5× ULN in absence of Gilbert's syndrome
Any suicidal ideation with intent with or without a plan, at the time of or within 6 months of Screening, as indicated by answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS)
Any suicidal behavior in the past based on the C-SSRS
Any history of anorexia or bulimia within 2 years before Screening, Attention Deficit Hyperactivity Disorder, any Diagnostic and Statistical Manual of Mental Disorders, 5th Edition depressive disorder, bipolar disorder, or schizophrenia
Known secondary causes (genetic, endocrine, or metabolic) for obesity (eg, Prader-Willi syndrome, Bardet Biedl syndrome, Down's Syndrome, untreated hypothyroidism, Cushing's syndrome, daily systemic corticosteroid exposure for longer than 30 days, history of significant exposure to corticosteroids for chronic illness during the past year; inhaled steroids will be allowed)
Use of other products intended for weight loss including prescription drugs, over-the-counter (OTC) drugs, and herbal preparations within 1 month before Screening
selective serotonin reuptake inhibitors
serotonin norepinephrine reuptake inhibitors
tricyclic antidepressants
bupropion
triptans
St. John's Wort
tryptophan
linezolid
dextromethorphan in any form (eg, OTC cold medicines)
lithium
tramadol
antipsychotics or other dopamine antagonists	
antiseizure medications including valproic acid, zonisamide, topiramate, and lamotrigine
oral steroids (topical and inhaled steroids are acceptable)
stimulant medications (eg, Ritalin, Concerta, Biphetamine, and Dexedrine)
benzodiazepines
Use of drugs known to increase the risk for cardiac valvulopathy within 6 months before Screening, including but not limited to pergolide, ergotamine, methysergide, and cabergoline
History or evidence of clinically significant disease (eg, malignancy; cardiac, respiratory, gastrointestinal, renal, or psychiatric disease) other than prediabetes (impaired fasting glucose or impaired glucose tolerance), type 2 diabetes treated with oral anti-diabetic agents (excluding sulfonylurea) or non-insulin injectable antidiabetic agents, obstructive sleep apnea, dyslipidemia, and nonalcoholic fatty liver disease
Use of Belviq XR within 6 months before Screening or hypersensitivity to Belviq XR or any of the excipients
Significant change in diet or level of physical activity within 1 month before dosing or change in weight of more than 5 kg within 3 months before Screening
Any use of a very-low-calorie (<1000 calories/day) weight loss diet within 6 months before Screening
History of alcohol or drug dependence or abuse
Recreational drug use within 2 years before Screening
Known to be human immunodeficiency virus positive
Known to have active viral hepatitis (B or C)
Malignancy within 5 years before Screening
Unable to attend scheduled visits (eg, lack of transportation) or lack of a caregiver or guardian to supervise study participation
Special needs participants who are unable to comprehend study-related instructions (eg, mild to profound mental retardation [intelligence quotient <70], moderate to severe cognitive developmental delay, pervasive development disorders, autism)
Ongoing epilepsy or other seizure disorder, or use of medications for a seizure disorder within 6 months of screening or any time between screening and randomization
Participants with a blood pressure in the 95th percentile or greater for age, sex, and height on 2 separate readings recorded on 2 separate days. Those participants who had uncontrolled hypertension at Screening can be rescreened more than 1 month after initiation or adjustment of antihypertensive therapy 1 time.
Currently enrolled in another clinical study or has used any investigational drug or device within 30 days before providing informed consent
Planned bariatric surgery during the study or prior bariatric surgical procedures
Not suitable to participate in the study in the opinion of the investigator, including consideration of any existing physical, medical, or mental condition that prevents compliance with the protocol
Female participants who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin test). A separate Baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 28 days after study drug discontinuation
Are currently abstinent and do not agree to use a double-barrier method (as described above) or refrain from sexual activity during the study period and for 28 days after study drug discontinuation
Are using hormonal contraceptives, but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study and for 28 days after study drug discontinuation (Note: All female participants will be considered to be of childbearing potential unless they have been sterilized surgically [ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing]).

NCT03338296_exc_T1
Qualifier
Clinically significant
NCT03338296_exc_T2
Qualifier
new
NCT03338296_exc_T3
Condition
illness
NCT03338296_exc_T4
Temporal
within 1 month before randomization
NCT03338296_exc_T5
Reference_point
randomization
NCT03338296_exc_T6
Observation
may affect the participant's ability to fulfill the study requirements
NCT03338296_exc_T7
Observation
significantly confound the assessments may
NCT03338296_exc_T8
Scope
may affect the participant's ability to fulfill the study requirements or significantly confound the assessments
NCT03338296_exc_T9
Observation
cannot swallow
NCT03338296_exc_T10
Drug
investigational products
NCT03338296_exc_T11
Condition
T2DM
NCT03338296_exc_T12
Condition
hypoglycemia unawareness
NCT03338296_exc_T13
Condition
Aortic regurgitation
NCT03338296_exc_T14
Qualifier
mild or greater
NCT03338296_exc_T15
Condition
Mitral regurgitation
NCT03338296_exc_T16
Qualifier
moderate or greater
NCT03338296_exc_T17
Condition
l or a  stenosis gre
NCT03338296_exc_T18
Condition
aortic valve stenosis
NCT03338296_exc_T19
Qualifier
greater than mild
NCT03338296_exc_T20
Scope
Mitral or aortic valve stenosis
NCT03338296_exc_T21
Condition
aortic stenosis
NCT03338296_exc_T22
Measurement
jet
NCT03338296_exc_T23
Value
>3.0 meters per second [m/s]
NCT03338296_exc_T24
Measurement
mean gradient
NCT03338296_exc_T25
Value
>25 millimeters of mercury [mmHg]
NCT03338296_exc_T26
Measurement
aortic valve area
NCT03338296_exc_T27
Value
<1.5 centimeters squared [cm^2]
NCT03338296_exc_T28
Condition
mitral stenosis
NCT03338296_exc_T29
Measurement
mean gradient
NCT03338296_exc_T30
Value
>5 mmHg
NCT03338296_exc_T31
Measurement
mitral valve area
NCT03338296_exc_T32
Value
<1.5 cm^2
NCT03338296_exc_T33
Scope
jet >3.0 meters per second [m/s], mean gradient >25 millimeters of mercury [mmHg], and aortic valve area <1.5 centimeters squared [cm^2]
NCT03338296_exc_T34
Scope
mean gradient >5 mmHg and mitral valve area <1.5 cm^2
NCT03338296_exc_T35
Scope
aortic stenosis: jet >3.0 meters per second [m/s], mean gradient >25 millimeters of mercury [mmHg], and aortic valve area <1.5 centimeters squared [cm^2]; mitral stenosis: mean gradient >5 mmHg and mitral valve area <1.5 cm^2
NCT03338296_exc_T36
Scope
Mitral or aortic valve stenosis greater than mild
NCT03338296_exc_T37
Measurement
Systolic pulmonary artery pressure (SPAP)
NCT03338296_exc_T38
Value
>40 mmHg
NCT03338296_exc_T39
Measurement
tricuspid regurgitation [TR] jet velocity
NCT03338296_exc_T40
Value
>2.9 m/s
NCT03338296_exc_T42
Measurement
RVOTAT
NCT03338296_exc_T43
Value
=100 milliseconds (msec)
NCT03338296_exc_T44
Measurement
Left ventricular ejection fraction
NCT03338296_exc_T45
Value
<45%
NCT03338296_exc_T46
Condition
Intracardiac mass
NCT03338296_exc_T47
Condition
tumor
NCT03338296_exc_T48
Condition
thrombus
NCT03338296_exc_T50
Condition
congenital heart disease
NCT03338296_exc_T51
Mood
Evidence of
NCT03338296_exc_T52
Qualifier
Clinically significant
NCT03338296_exc_T53
Condition
pericardial effusion
NCT03338296_exc_T54
Qualifier
moderate or larger
NCT03338296_exc_T55
Condition
hemodynamic compromise
NCT03338296_exc_T56
Scope
moderate or larger or with hemodynamic compromise
NCT03338296_exc_T57
Qualifier
Significant
NCT03338296_exc_T58
Condition
hepatic disease
NCT03338296_exc_T59
Condition
patic evidenc
NCT03338296_exc_T60
Scope
renal or hepatic disease
NCT03338296_exc_T61
Measurement
serum creatinine
NCT03338296_exc_T62
Value
greater than 1.5× upper limit of normal (ULN)
NCT03338296_exc_T63
Measurement
serum transaminases
NCT03338296_exc_T64
Value
greater than 3× ULN
NCT03338296_exc_T65
Measurement
total bilirubin
NCT03338296_exc_T66
Value
greater than 1.5× ULN
NCT03338296_exc_T67
Negation
absence of
NCT03338296_exc_T68
Condition
Gilbert's syndrome
NCT03338296_exc_T69
Scope
serum creatinine greater than 1.5× upper limit of normal (ULN), serum transaminases greater than 3× ULN, or total bilirubin greater than 1.5× ULN in absence of Gilbert's syndrome
NCT03338296_exc_T70
Condition
suicidal ideation
NCT03338296_exc_T71
Qualifier
with intent
NCT03338296_exc_T72
Qualifier
without a plan
NCT03338296_exc_T73
Qualifier
out he tim
NCT03338296_exc_T74
Scope
with or without a plan
NCT03338296_exc_T75
Temporal
of or within 6 s indicat
NCT03338296_exc_T76
Temporal
within 6 months of Screening
NCT03338296_exc_T77
Scope
at the time of or within 6 months of Screening
NCT03338296_exc_T78
Procedure
Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS)
NCT03338296_exc_T79
Measurement
questions 4
NCT03338296_exc_T80
Measurement
or 5 on t c
NCT03338296_exc_T81
Value
Yes
NCT03338296_exc_T82
Scope
questions 4 or 5
NCT03338296_exc_T83
Condition
suicidal behavior
NCT03338296_exc_T84
Temporal
in the past
NCT03338296_exc_T85
Procedure
C-SSRS
NCT03338296_exc_T86
Observation
history
NCT03338296_exc_T87
Condition
anorexia
NCT03338296_exc_T88
Condition
bulimia
NCT03338296_exc_T89
Temporal
within 2 years before Screening
NCT03338296_exc_T90
Reference_point
Screening
NCT03338296_exc_T91
Scope
anorexia or bulimia
NCT03338296_exc_T92
Condition
Attention Deficit Hyperactivity Disorder
NCT03338296_exc_T93
Qualifier
Diagnostic and Statistical Manual of Mental Disorders, 5th Edition
NCT03338296_exc_T94
Condition
depressive disorder
NCT03338296_exc_T95
Condition
bipolar disorder
NCT03338296_exc_T96
Condition
schizophrenia
NCT03338296_exc_T97
Scope
depressive disorder, bipolar disorder, or schizophrenia
NCT03338296_exc_T98
Condition
s (genetic, endo , Prader-Wi
NCT03338296_exc_T99
Qualifier
genetic
NCT03338296_exc_T100
Qualifier
endocrine
NCT03338296_exc_T101
Qualifier
metabolic
NCT03338296_exc_T102
Scope
genetic, endocrine, or metabolic
NCT03338296_exc_T103
Condition
Prader-Willi syndrome
NCT03338296_exc_T104
Condition
Bardet Biedl syndrome
NCT03338296_exc_T105
Condition
Down's Syndrome
NCT03338296_exc_T106
Condition
untreated hypothyroidism
NCT03338296_exc_T107
Condition
Cushing's syndrome
NCT03338296_exc_T108
Multiplier
daily
NCT03338296_exc_T109
Drug
systemic corticosteroid
NCT03338296_exc_T110
Temporal
for longer than 30 days
NCT03338296_exc_T111
Observation
history
NCT03338296_exc_T112
Qualifier
significant exposure
NCT03338296_exc_T113
Drug
corticosteroids
NCT03338296_exc_T114
Condition
chronic illness
NCT03338296_exc_T115
Temporal
during the past year
NCT03338296_exc_T117
Scope
Prader-Willi syndrome, Bardet Biedl syndrome, Down's Syndrome, untreated hypothyroidism, Cushing's syndrome, daily systemic corticosteroid exposure for longer than 30 days, history of significant exposure to corticosteroids for chronic illness during the past year; inhaled steroids will be allowed
NCT03338296_exc_T118
Scope
secondary causes (genetic, endocrine, or metabolic) for obesity
NCT03338296_exc_T119
Drug
products intended for weight loss
NCT03338296_exc_T120
Qualifier
prescription
NCT03338296_exc_T121
Qualifier
over-the-counter (OTC)
NCT03338296_exc_T122
Qualifier
herbal
NCT03338296_exc_T123
Temporal
within 1 month before Screening
NCT03338296_exc_T124
Reference_point
Screening
NCT03338296_exc_T125
Scope
prescription drugs, over-the-counter (OTC) drugs, and herbal
NCT03338296_exc_T126
Drug
selective serotonin reuptake inhibitors
NCT03338296_exc_T127
Drug
serotonin norepinephrine reuptake inhibitors
NCT03338296_exc_T128
Drug
tricyclic antidepressants
NCT03338296_exc_T129
Drug
bupropion
NCT03338296_exc_T130
Drug
triptans
NCT03338296_exc_T131
Drug
St. John's Wort
NCT03338296_exc_T132
Drug
tryptophan
NCT03338296_exc_T133
Drug
linezolid
NCT03338296_exc_T134
Drug
dextromethorphan
NCT03338296_exc_T135
Qualifier
any form
NCT03338296_exc_T136
Drug
lithium
NCT03338296_exc_T137
Drug
tramadol
NCT03338296_exc_T138
Drug
antipsychotics
NCT03338296_exc_T139
Drug
dopamine antagonists
NCT03338296_exc_T140
Drug
antiseizure medications
NCT03338296_exc_T141
Drug
valproic acid
NCT03338296_exc_T142
Drug
zonisamide
NCT03338296_exc_T143
Drug
topiramate
NCT03338296_exc_T144
Drug
lamotrigine
NCT03338296_exc_T145
Scope
valproic acid, zonisamide, topiramate, and lamotrigine
NCT03338296_exc_T146
Drug
oral steroids
NCT03338296_exc_T147
Drug
inhaled steroids
NCT03338296_exc_T148
Drug
re acce lant med
NCT03338296_exc_T149
Negation
acceptable
NCT03338296_exc_T150
Scope
topical and inhaled steroids
NCT03338296_exc_T151
Drug
stimulant medications
NCT03338296_exc_T152
Drug
Ritalin
NCT03338296_exc_T153
Drug
Concerta
NCT03338296_exc_T154
Drug
Biphetamine
NCT03338296_exc_T155
Drug
Dexedrine
NCT03338296_exc_T156
Scope
Ritalin, Concerta, Biphetamine, and Dexedrine
NCT03338296_exc_T157
Drug
benzodiazepines
NCT03338296_exc_T158
Drug
drugs
NCT03338296_exc_T159
Condition
cardiac valvulopathy
NCT03338296_exc_T160
Temporal
within 6 months before Screening
NCT03338296_exc_T161
Drug
pergolide
NCT03338296_exc_T162
Drug
ergotamine
NCT03338296_exc_T163
Drug
methysergide
NCT03338296_exc_T164
Drug
cabergoline
NCT03338296_exc_T165
Scope
pergolide, ergotamine, methysergide, and cabergoline
NCT03338296_exc_T166
Qualifier
known to increase the risk for cardiac valvulopathy
NCT03338296_exc_T167
Scope
drugs known to increase the risk for cardiac valvulopathy
NCT03338296_exc_T168
Observation
History
NCT03338296_exc_T169
Qualifier
clinically significant
NCT03338296_exc_T170
Condition
disease
NCT03338296_exc_T171
Condition
malignancy
NCT03338296_exc_T172
Qualifier
cardiac
NCT03338296_exc_T173
Qualifier
respiratory
NCT03338296_exc_T174
Qualifier
gastrointestinal
NCT03338296_exc_T175
Qualifier
renal
NCT03338296_exc_T176
Qualifier
psychiatric
NCT03338296_exc_T177
Condition
disease
NCT03338296_exc_T178
Scope
cardiac, respiratory, gastrointestinal, renal, or psychiatric
NCT03338296_exc_T179
Scope
cardiac, respiratory, gastrointestinal, renal, or psychiatric disease
NCT03338296_exc_T180
Scope
History or evidence of clinically significant
NCT03338296_exc_T181
Scope
History or evidence of clinically significant disease
NCT03338296_exc_T182
Scope
malignancy; cardiac, respiratory, gastrointestinal, renal, or psychiatric disease
NCT03338296_exc_T183
Negation
other than
NCT03338296_exc_T184
Condition
prediabetes
NCT03338296_exc_T185
Value
impaired
NCT03338296_exc_T186
Measurement
fasting glucose
NCT03338296_exc_T187
Condition
impaired glucose tolerance
NCT03338296_exc_T188
Condition
impaired fasting glucose
NCT03338296_exc_T189
Condition
type 2 diabetes
NCT03338296_exc_T190
Drug
oral anti-diabetic agents
NCT03338296_exc_T191
Drug
sulfonylurea
NCT03338296_exc_T192
Negation
excluding
NCT03338296_exc_T193
Scope
excluding sulfonylurea
NCT03338296_exc_T194
Qualifier
non-insulin
NCT03338296_exc_T195
Qualifier
injectable
NCT03338296_exc_T196
Drug
antidiabetic agents
NCT03338296_exc_T197
Condition
obstructive sleep apnea
NCT03338296_exc_T198
Condition
dyslipidemia
NCT03338296_exc_T199
Condition
nonalcoholic fatty liver disease
NCT03338296_exc_T200
Scope
oral anti-diabetic agents (excluding sulfonylurea) or non-insulin injectable antidiabetic agents
NCT03338296_exc_T201
Scope
impaired fasting glucose or impaired glucose tolerance)
NCT03338296_exc_T202
Drug
Belviq XR
NCT03338296_exc_T203
Temporal
within 6 months before Screening
NCT03338296_exc_T204
Reference_point
Screening
NCT03338296_exc_T205
Condition
hypersensitivity
NCT03338296_exc_T206
Drug
Belviq XR
NCT03338296_exc_T207
Qualifier
or any of the excipients
NCT03338296_exc_T208
Observation
change in diet
NCT03338296_exc_T209
Qualifier
Significant
NCT03338296_exc_T210
Observation
activity month before dosing or cha
NCT03338296_exc_T211
Temporal
within 1 month before dosing
NCT03338296_exc_T212
Reference_point
dosing
NCT03338296_exc_T213
Scope
change in diet or level of physical activity
NCT03338296_exc_T214
Observation
change in weight
NCT03338296_exc_T215
Value
more than 5 kg
NCT03338296_exc_T216
Temporal
within 3 months before Screening
NCT03338296_exc_T217
Reference_point
Screening
NCT03338296_exc_T218
Observation
 weight loss di re Screening
His
NCT03338296_exc_T219
Value
<1000 calories/day
NCT03338296_exc_T220
Temporal
within 6 months before Screening
NCT03338296_exc_T221
Reference_point
Screening
NCT03338296_exc_T222
Observation
History
NCT03338296_exc_T223
Condition
creatio ears
NCT03338296_exc_T224
Condition
drug dependence
NCT03338296_exc_T225
Condition
drug ears
NCT03338296_exc_T226
Condition
creatio use within
NCT03338296_exc_T227
Scope
alcohol or drug dependence or abuse
NCT03338296_exc_T228
Observation
Recreational drug use
NCT03338296_exc_T229
Temporal
within 2 years before Screening
NCT03338296_exc_T230
Reference_point
Screening
NCT03338296_exc_T231
Condition
human immunodeficiency virus positive
NCT03338296_exc_T232
Measurement
human immunodeficiency virus
NCT03338296_exc_T233
Value
positive
NCT03338296_exc_T234
Condition
viral hepatitis
NCT03338296_exc_T235
Qualifier
active
NCT03338296_exc_T236
Qualifier
B
NCT03338296_exc_T237
Qualifier
C
NCT03338296_exc_T238
Scope
B or C
NCT03338296_exc_T239
Condition
Malignancy
NCT03338296_exc_T240
Temporal
within 5 years before Screening
NCT03338296_exc_T241
Reference_point
Screening
NCT03338296_exc_T242
Observation
Unable to attend scheduled visits
NCT03338296_exc_T243
Observation
lack of transportation
NCT03338296_exc_T244
Observation
lack of a caregiver
NCT03338296_exc_T245
Observation
e study pecial n
NCT03338296_exc_T246
Observation
Special needs
NCT03338296_exc_T247
Observation
ons (eg, mild to pro tardation [i
NCT03338296_exc_T248
Qualifier
study-related
NCT03338296_exc_T249
Qualifier
mild to profound
NCT03338296_exc_T250
Condition
mental retardation
NCT03338296_exc_T251
Measurement
intelligence quotient
NCT03338296_exc_T252
Value
<70
NCT03338296_exc_T253
Qualifier
moderate to severe
NCT03338296_exc_T254
Condition
cognitive developmental delay
NCT03338296_exc_T255
Condition
pervasive development disorders
NCT03338296_exc_T256
Condition
autism
NCT03338296_exc_T257
Scope
intelligence quotient <70
NCT03338296_exc_T258
Scope
mild to profound mental retardation
NCT03338296_exc_T259
Scope
mild to profound mental retardation [intelligence quotient <70], moderate to severe cognitive developmental delay, pervasive development disorders, autism
NCT03338296_exc_T260
Scope
unable to comprehend study-related instructions
NCT03338296_exc_T261
Temporal
Ongoing
NCT03338296_exc_T262
Condition
epilepsy
NCT03338296_exc_T263
Qualifier
Ongoing
NCT03338296_exc_T264
Condition
seizure disorder
NCT03338296_exc_T265
Qualifier
other
NCT03338296_exc_T266
Drug
medications
NCT03338296_exc_T267
Condition
seizure disorder
NCT03338296_exc_T268
Temporal
within 6 months of screening
NCT03338296_exc_T269
Reference_point
screening
NCT03338296_exc_T270
Temporal
any time between screening and randomization
NCT03338296_exc_T271
Reference_point
screening
NCT03338296_exc_T272
Reference_point
randomization
NCT03338296_exc_T273
Scope
within 6 months of screening or any time between screening and randomization
NCT03338296_exc_T274
Measurement
blood pressure
NCT03338296_exc_T275
Value
95th percentile or greater
NCT03338296_exc_T276
Qualifier
for age
NCT03338296_exc_T277
Qualifier
s r d o
NCT03338296_exc_T278
Qualifier
s r parate
NCT03338296_exc_T279
Multiplier
2 separate readings
NCT03338296_exc_T280
Qualifier
2 separate days
NCT03338296_exc_T282
Observation
any investi drug or device
NCT03338296_exc_T283
Qualifier
another
NCT03338296_exc_T284
Temporal
Currently
NCT03338296_exc_T285
Drug
investigational drug
NCT03338296_exc_T286
Temporal
within 30 days before providing informed consent
NCT03338296_exc_T287
Device
device
NCT03338296_exc_T288
Scope
investigational drug or device
NCT03338296_exc_T289
Mood
Planned
NCT03338296_exc_T290
Procedure
bariatric surgery
NCT03338296_exc_T291
Temporal
during the study
NCT03338296_exc_T292
Reference_point
the study
NCT03338296_exc_T293
Temporal
prior
NCT03338296_exc_T294
Procedure
bariatric surgical procedures
NCT03338296_exc_T296
Person
Female
NCT03338296_exc_T297
Observation
breastfeeding
NCT03338296_exc_T298
Condition
pregnant
NCT03338296_exc_T299
Temporal
at Screening
NCT03338296_exc_T300
Temporal
iv horionic
NCT03338296_exc_T301
Scope
breastfeeding or pregnant
NCT03338296_exc_T302
Scope
at Screening or Baseline
NCT03338296_exc_T303
Measurement
beta-human chorionic gonadotropin test
NCT03338296_exc_T304
Value
positive
NCT03338296_exc_T305
Value
negative
NCT03338296_exc_T306
Measurement
screening pregnancy test
NCT03338296_exc_T307
Qualifier
separate
NCT03338296_exc_T308
Procedure
Baseline assessment
NCT03338296_exc_T309
Temporal
more than 72 hours before the first dose of study drug
NCT03338296_exc_T310
Reference_point
the first dose of study drug
NCT03338296_exc_T311
Scope
negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug
NCT03338296_exc_T312
Scope
positive beta-human chorionic gonadotropin test
NCT03338296_exc_T313
Scope
separate Baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug
NCT03338296_exc_T314
Condition
unprotected sexual intercourse
NCT03338296_exc_T315
Temporal
within 30 days before study entry
NCT03338296_exc_T316
Reference_point
study entry
NCT03338296_exc_T317
Observation
do not agree
NCT03338296_exc_T318
Qualifier
highly effective
NCT03338296_exc_T319
Observation
method of contraception
NCT03338296_exc_T320
Measurement
abstinence
NCT03338296_exc_T321
Value
total
NCT03338296_exc_T322
Device
intrauterine device
NCT03338296_exc_T323
Observation
double-barrier method
NCT03338296_exc_T324
Device
condom
NCT03338296_exc_T325
Device
diaphragm with spermicide
NCT03338296_exc_T326
Scope
condom plus diaphragm with spermicide
NCT03338296_exc_T327
Device
contraceptive implant
NCT03338296_exc_T328
Drug
oral contraceptive
NCT03338296_exc_T329
Procedure
vasectomized
NCT03338296_exc_T330
Person
partner
NCT03338296_exc_T331
Condition
azoospermia
NCT03338296_exc_T332
Scope
condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia
NCT03338296_exc_T333
Temporal
throughout the entire study period
NCT03338296_exc_T334
Temporal
for 28 days after study drug discontinuation
NCT03338296_exc_T335
Reference_point
the entire study period
NCT03338296_exc_T336
Reference_point
study drug discontinuation
NCT03338296_exc_T337
Drug
study drug
NCT03338296_exc_T338
Scope
total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia
NCT03338296_exc_T339
Scope
highly effective method of contraception
NCT03338296_exc_T340
Condition
abstinent
NCT03338296_exc_T341
Temporal
currently
NCT03338296_exc_T342
Observation
double-barrier method
NCT03338296_exc_T343
Observation
do not agree
NCT03338296_exc_T344
Observation
sexual activity
NCT03338296_exc_T345
Negation
refrain
NCT03338296_exc_T346
Temporal
during the study period
NCT03338296_exc_T347
Temporal
for 28 days after study drug discontinuation
NCT03338296_exc_T348
Reference_point
the study period
NCT03338296_exc_T349
Reference_point
study drug discontinuation
NCT03338296_exc_T350
Drug
study drug
NCT03338296_exc_T351
Scope
during the study period and for 28 days after study drug discontinuation
NCT03338296_exc_T352
Scope
double-barrier method (as described above) or refrain from sexual activity
NCT03338296_exc_T353
Drug
hormonal contraceptives
NCT03338296_exc_T354
Negation
not
NCT03338296_exc_T355
Qualifier
stable dose
NCT03338296_exc_T356
Drug
hormonal contraceptive
NCT03338296_exc_T357
Temporal
for at least 4 weeks before dosing
NCT03338296_exc_T358
Drug
contraceptive
NCT03338296_exc_T359
Temporal
during the study
NCT03338296_exc_T360
Temporal
for 28 days after study drug discontinuation
NCT03338296_exc_T361
Reference_point
study drug discontinuation
NCT03338296_exc_T362
Observation
do not agree
NCT03338296_exc_T363
Qualifier
the same
NCT03338296_exc_T364
Qualifier
the same