Any condition/illness that may affect the study outcomes or would make participation potentially harmful such as pregnancy or breastfeeding, diabetes mellitus, heart disease, stroke, hypertension, malabsorption syndromes, GERD, a history of ulcer, according to a detailed medical history. 
Abnormal hepatic function (liver function test > twice the normal range), abnormal renal function (creatinine > 1.1 mg/dl), fasting plasma glucose in the diabetic range (>/= 126 mg/dl), or blood pressure > 140/90 mmHg. 
Present alcoholism or drug abuse or use of medications that could interfere with the treatment including bronchodilators, quinolone antibiotics, monoamine oxidase inhibitors, anxiolytics, ranitidine, corticosteroids, growth hormone, antihypertensives.       
    

NCT00305097_exc_T1
Condition
pregnancy
NCT00305097_exc_T2
Observation
breastfeeding
NCT00305097_exc_T3
Condition
diabetes mellitus
NCT00305097_exc_T4
Condition
heart disease
NCT00305097_exc_T5
Condition
stroke
NCT00305097_exc_T6
Condition
hypertension
NCT00305097_exc_T7
Condition
malabsorption syndromes
NCT00305097_exc_T8
Condition
GERD
NCT00305097_exc_T9
Observation
history of
NCT00305097_exc_T10
Condition
ulcer
NCT00305097_exc_T11
Condition
illness that may affect the study outcomes
NCT00305097_exc_T12
Condition
illness that would make participation potentially harmful
NCT00305097_exc_T13
Scope
pregnancy or breastfeeding, diabetes mellitus, heart disease, stroke, hypertension, malabsorption syndromes, GERD, a history of ulcer
NCT00305097_exc_T14
Scope
illness that may affect the study outcomes or would make participation potentially harmful
NCT00305097_exc_T15
Measurement
hepatic function
NCT00305097_exc_T16
Value
Abnormal
NCT00305097_exc_T17
Measurement
liver function test
NCT00305097_exc_T18
Value
> twice the normal range
NCT00305097_exc_T19
Measurement
renal function
NCT00305097_exc_T20
Value
abnormal
NCT00305097_exc_T21
Measurement
creatinine
NCT00305097_exc_T22
Value
> 1.1 mg/dl
NCT00305097_exc_T23
Measurement
fasting plasma glucose
NCT00305097_exc_T24
Value
in the diabetic range
NCT00305097_exc_T25
Value
>/= 126 mg/dl
NCT00305097_exc_T26
Measurement
blood pressure
NCT00305097_exc_T27
Value
> 140/90 mmHg
NCT00305097_exc_T28
Condition
alcoholism
NCT00305097_exc_T29
Condition
drug abuse
NCT00305097_exc_T30
Drug
medications that could interfere with the treatment
NCT00305097_exc_T31
Drug
bronchodilators
NCT00305097_exc_T32
Drug
quinolone antibiotics
NCT00305097_exc_T33
Drug
monoamine oxidase inhibitors
NCT00305097_exc_T34
Drug
anxiolytics
NCT00305097_exc_T35
Drug
ranitidine
NCT00305097_exc_T36
Drug
corticosteroids
NCT00305097_exc_T37
Drug
growth hormone
NCT00305097_exc_T38
Drug
antihypertensives
NCT00305097_exc_T39
Scope
bronchodilators, quinolone antibiotics, monoamine oxidase inhibitors, anxiolytics, ranitidine, corticosteroids, growth hormone, antihypertensives
NCT00305097_exc_T40
Observation
medical history