Clinical Trials List
Protocol NumberI8D-MC-AZET
NCT Number(ClinicalTrials.gov Identfier)NCT02783573
2016-09-30 - 2018-12-31
Phase III
Terminated10
ICD-10G30
Alzheimer's disease
ICD-10G30.9
Alzheimer's disease, unspecified
ICD-9331.0
Alzheimer's disease
A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer′s Disease Dementia (The DAYBREAK Study)
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Eli Lilly and Company
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 許聖民 Division of Ophthalmology
- Chao-Chun Yang Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
- 陳世彬 Division of Neurology
- Shuu-Jiun Wang Division of Neurology
- An-Fei Li Division of Ophthalmology
- YEN-FENG WANG Division of Neurology
- 陳世彬 Division of Neurology
- Yun-Ting Chang Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 郭怡真 Division of Neurology
- TING-BIN CHEN Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 王鼎舜 Division of Dermatology
- Tzu-Ting Chen Division of Psychiatry
- 王律鈞 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Linkou Chang Gung Medical Foundation
Taiwan National PI
黃錦章
Co-Principal Investigator
- Chi-Chun Lai Division of Ophthalmology
- KuoLun Huang Division of Neurology
- Ya-Ching Chang Division of Dermatology
The Actual Total Number of Participants Enrolled
3 Stop recruiting
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
- mei feng Huang Division of Psychiatry
- Cheng-Che Lan Division of Dermatology
- Yi-Chun Yeh Division of Psychiatry
- Yu-Hung Lai Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Mild Alzheimer′s Disease
Objectives
Ⅴ.Assessment criteria
1. Efficacy: Cognitive function will be assessed by using a 13-item version of ADAS-Cog. Change in the primary endpoint measure, ADAS-Cog13 from baseline to the end of the Placebo- Controlled period.
2. Safety: Standard safety assessments include spontaneously reported AEs, clinical laboratory tests, vital sign and body weight measurements, 12-lead ECGs, and physical examinations including neurological examinations. The additional safety assessments are eye examinations, skin examinations, serial MRI, C-SSRS.
3. Pharmacokinetics: Apparent Oral Clearance of LY3314814 and Central Volume of Distribution of LY3314814
4. Quality of life: NA
Test Drug
LY3314814
Active Ingredient
LY3314314
Dosage Form
tablet
Dosage
20, 50
Endpoints
Primary Objective
To test the hypothesis that LY3314814, administered orally at doses of 20 and 50 mg daily for 78 weeks, will slow the decline of AD as compared with placebo in patients with mild AD dementia
Secondary Objectives
Clinical efficacy objectives:
• To evaluate the efficacy of LY3314814 on functional, clinical, and cognitive outcomes in patients with mild AD dementia at the end of the Placebo-Controlled period (week 78). The order of testing and control of Type 1 error will be prespecified with a graphical analysis as stated in the Statistical Analysis Plan.
• To evaluate the relationship between treatment effect of LY3314814 and time (at points other than the end of the Placebo-Controlled period [week 78], such as week 26 and week 52). Specific time points will vary by instrument.
• To test the hypothesis that LY3314814 will slow the rate of cognitive and functional decline associated with AD, compared with placebo
• To evaluate the efficacy of LY3314814 to prolong time in the current disease state
Biomarker objectives:
• To evaluate the effect of LY3314814 on CSF Aβ PD markers
• To evaluate the effect of LY3314814 on CSF markers of neurodegeneration
• To evaluate the effect of LY3314814 on brain amyloid burden
• To evaluate the effect of LY3314814 on regional cerebral blood flow (rCBF)
• To evaluate the effect of LY3314814 on brain aggregated tau levels
• To evaluate the effect of LY3314814 on brain metabolism
• To evaluate the effect of LY3314814 on brain atrophy
Pharmacokinetic objective:
• To assess the population PK of LY3314814 and metabolite AZ13569724 in patients with mild AD dementia
To test the hypothesis that LY3314814, administered orally at doses of 20 and 50 mg daily for 78 weeks, will slow the decline of AD as compared with placebo in patients with mild AD dementia
Secondary Objectives
Clinical efficacy objectives:
• To evaluate the efficacy of LY3314814 on functional, clinical, and cognitive outcomes in patients with mild AD dementia at the end of the Placebo-Controlled period (week 78). The order of testing and control of Type 1 error will be prespecified with a graphical analysis as stated in the Statistical Analysis Plan.
• To evaluate the relationship between treatment effect of LY3314814 and time (at points other than the end of the Placebo-Controlled period [week 78], such as week 26 and week 52). Specific time points will vary by instrument.
• To test the hypothesis that LY3314814 will slow the rate of cognitive and functional decline associated with AD, compared with placebo
• To evaluate the efficacy of LY3314814 to prolong time in the current disease state
Biomarker objectives:
• To evaluate the effect of LY3314814 on CSF Aβ PD markers
• To evaluate the effect of LY3314814 on CSF markers of neurodegeneration
• To evaluate the effect of LY3314814 on brain amyloid burden
• To evaluate the effect of LY3314814 on regional cerebral blood flow (rCBF)
• To evaluate the effect of LY3314814 on brain aggregated tau levels
• To evaluate the effect of LY3314814 on brain metabolism
• To evaluate the effect of LY3314814 on brain atrophy
Pharmacokinetic objective:
• To assess the population PK of LY3314814 and metabolite AZ13569724 in patients with mild AD dementia
Inclution Criteria
Inclusion Criteria
Patients with mild AD dementia are eligible to be included in the study only if they meet all of
the following criteria at screening.
General Criteria
[1] Provision of signed and dated informed consent form (ICF) from patient (or legal
representative if required) and from study partner prior to any study-specific
procedures being performed
[2] Male or female, aged 55 to 85 years inclusive at the time of signing ICF
Diagnostic Criteria
[3] Patient must meet the National Institute on Aging (NIA) and the Alzheimer’s
Association (AA) (NIA-AA) criteria for probable AD dementia (McKhann et al.
2011)
[4] Mini-Mental State Examination (MMSE) score of 20 to 26 inclusive at screening visit
[5] For a diagnosis of mild AD dementia, patient must have a Clinical Dementia Rating
(CDR) global score of 0.5 or 1, with the memory box score ≥0.5 at screening
[6] Florbetapir F 18 positron emission tomography (PET) or CSF A1-42 positive by
central assessor for presence of amyloid
Note: Historical amyloid PET scans can be submitted. Note that central reading vendor for this study
must confirm amyloid positivity for study eligibility. If either the florbetapir PET, historical amyloid
PET or CSF A1-42 result is negative for amyloid, patient cannot retest with other diagnostic measure.
If either diagnostic is attempted but can’t be completed to a final result then the test may be repeated or
the alternative test can be used if available.
Contraception
[7] Women must be postmenopausal, surgically sterile, or having infertility due to
congenital anomaly. A postmenopausal woman is defined as either having an intact
uterus with at least 6 months of spontaneous amenorrhea or a diagnosis of menopause
prior to starting hormone replacement therapy. Surgically sterile women are defined
as those who have had a hysterectomy, bilateral ovariectomy (oophorectomy), or bilateral tubal ligation.
[8] Men with pregnant partners should use condoms from the first day of dosing
until 3 months after the last dose of study treatment and abstain for 24 hours
after dose administration of the florbetapir, AV-1451 or fludeoxyglucose (FDG) PET tracer.
Men with partners of childbearing potential must abstain or use condoms plus
an additional effective form of contraception from the first day of dosing until
3 months after the last dose of study treatment and abstain for 24 hours after
dose administration of the florbetapir, AV-1451 or FDG PET tracer. For this
protocol, sexual abstinence is defined as refraining from heterosexual
intercourse during the entire period of risk associated with the study treatment.
True abstinence is only acceptable when it is in line with the patient’s usual and preferred lifestyle.
Concomitant Medication Criteria
[9] All medication dosing should be stable for at least 30 days before screening, and
between screening and randomization (does not apply to medications discontinued)
Procedural Criteria
[10] Must have completed 6 years of formal education and/or have a history of academic
achievement and/or employment sufficient to exclude lifelong intellectual disability
[11] The patient must have a reliable study partner with whom he/she cohabits or has
regular contact (combination of face-to-face visits/ telephone contact acceptable). If
at all possible, the same study partner should be willing to participate in study visits
to provide meaningful input into the rating scales administered in this study, where
study partner input is required or be available by telephone and must have sufficient
patient interaction. As guidance, the ability for a study partner to meet his/her expected responsibilities for this study would normally be possible when the study partner spends no less than 10 hours per week with the subject, divided over multiple days.
(12) Patient and study partner must be able to read, write, and speak the language in which psychometric tests are provided, with acceptable visual and auditory acuity (corrected)
(13) Study partner must be cognitively able to fulfill the requirements of the study, in the opinion of the investigator
Patients with mild AD dementia are eligible to be included in the study only if they meet all of
the following criteria at screening.
General Criteria
[1] Provision of signed and dated informed consent form (ICF) from patient (or legal
representative if required) and from study partner prior to any study-specific
procedures being performed
[2] Male or female, aged 55 to 85 years inclusive at the time of signing ICF
Diagnostic Criteria
[3] Patient must meet the National Institute on Aging (NIA) and the Alzheimer’s
Association (AA) (NIA-AA) criteria for probable AD dementia (McKhann et al.
2011)
[4] Mini-Mental State Examination (MMSE) score of 20 to 26 inclusive at screening visit
[5] For a diagnosis of mild AD dementia, patient must have a Clinical Dementia Rating
(CDR) global score of 0.5 or 1, with the memory box score ≥0.5 at screening
[6] Florbetapir F 18 positron emission tomography (PET) or CSF A1-42 positive by
central assessor for presence of amyloid
Note: Historical amyloid PET scans can be submitted. Note that central reading vendor for this study
must confirm amyloid positivity for study eligibility. If either the florbetapir PET, historical amyloid
PET or CSF A1-42 result is negative for amyloid, patient cannot retest with other diagnostic measure.
If either diagnostic is attempted but can’t be completed to a final result then the test may be repeated or
the alternative test can be used if available.
Contraception
[7] Women must be postmenopausal, surgically sterile, or having infertility due to
congenital anomaly. A postmenopausal woman is defined as either having an intact
uterus with at least 6 months of spontaneous amenorrhea or a diagnosis of menopause
prior to starting hormone replacement therapy. Surgically sterile women are defined
as those who have had a hysterectomy, bilateral ovariectomy (oophorectomy), or bilateral tubal ligation.
[8] Men with pregnant partners should use condoms from the first day of dosing
until 3 months after the last dose of study treatment and abstain for 24 hours
after dose administration of the florbetapir, AV-1451 or fludeoxyglucose (FDG) PET tracer.
Men with partners of childbearing potential must abstain or use condoms plus
an additional effective form of contraception from the first day of dosing until
3 months after the last dose of study treatment and abstain for 24 hours after
dose administration of the florbetapir, AV-1451 or FDG PET tracer. For this
protocol, sexual abstinence is defined as refraining from heterosexual
intercourse during the entire period of risk associated with the study treatment.
True abstinence is only acceptable when it is in line with the patient’s usual and preferred lifestyle.
Concomitant Medication Criteria
[9] All medication dosing should be stable for at least 30 days before screening, and
between screening and randomization (does not apply to medications discontinued)
Procedural Criteria
[10] Must have completed 6 years of formal education and/or have a history of academic
achievement and/or employment sufficient to exclude lifelong intellectual disability
[11] The patient must have a reliable study partner with whom he/she cohabits or has
regular contact (combination of face-to-face visits/ telephone contact acceptable). If
at all possible, the same study partner should be willing to participate in study visits
to provide meaningful input into the rating scales administered in this study, where
study partner input is required or be available by telephone and must have sufficient
patient interaction. As guidance, the ability for a study partner to meet his/her expected responsibilities for this study would normally be possible when the study partner spends no less than 10 hours per week with the subject, divided over multiple days.
(12) Patient and study partner must be able to read, write, and speak the language in which psychometric tests are provided, with acceptable visual and auditory acuity (corrected)
(13) Study partner must be cognitively able to fulfill the requirements of the study, in the opinion of the investigator
Exclusion Criteria
2. Main exclusion criteria:
Patients will be excluded from study enrollment if they meet any of the following criteria at screening:
(14) Significant and/or current neurological disease affecting the central nervous system, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, repetitive head trauma, serious infection of the brain, Parkinson’s disease, epilepsy, or cervicocranial vascular disease.
(15) Patients with any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessment, or affect the patient’s ability to complete the study. Patients with history of schizophrenia or other chronic psychosis are excluded.
(16) History of alcohol or drug use disorder (except tobacco use disorder) within 2 years before the screening visit
(17) Within 1 year before the screening visit or between screening and randomization, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptoms of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (such as, significant valvular disease, hypertrophic cardiomyopathy); or hospitalization for arrhythmia
(18) Congenital QT prolongation
(19) Intermittent second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia
(20) A corrected QT (QTcF) interval measurement >470 msec (men and women) at screening (as determined at the investigational site)
(21) History of malignant cancer within the last 5 years
Note: The following is a partial list of conditions that are permissible for study entry: non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical, or non-progressive prostate cancer
(22) Current serious or unstable clinically important systemic illness that, in the judgment of the investigator, is likely to affect cognitive assessment, deteriorate, or affect the patient’s safety or ability to complete the study, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders
(23) History of vitiligo and/or current evidence of post-inflammatory hypopigmentation
(24) Severe drug allergy or anaphylaxis to 2 or more drugs classes
(25) Screening magnetic resonance imaging (MRI) shows evidence of >5 microhemorrhages; prior macrohemorrhage (>1 cm3); ≥4 infarcts, evidence of cerebral contusion, encephalomalacia, space-occupying lesion with mass-effect and edema
Note: Cortical superficial siderosis is not an exclusion.
(26) Uncontrolled hypertension, that is, supine systolic blood pressure >165 mmHg or diastolic blood pressure >95 mmHg. If an initial blood pressure reading is higher than this, an additional attempt (at this visit or on another day) could be used before excluding a patient for uncontrolled hypertension.
(27) Known positive serologic findings for human immunodeficiency virus (HIV) antibodies. Local laws and regulations may apply to whether testing is required.
(28) Patients with past history (suspected or confirmed) of Hepatitis B should have HBsAg testing at screening and are excluded if HBsAg is positive.
Patients with past history (suspected or confirmed) of Hepatitis C (resolved >6 months prior to enrollment) should have hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing at screening and are excluded if HCV RNA PCR is positive.
Patients in high-prevalence regions may be required to have screening serology.
(29) Any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital sign, ECG, or clinical laboratory test results that could be detrimental to the patient or could compromise the study
(30) Calculated creatinine clearance <30 mL/min (Cockcroft-Gault formula; Cockcroft and Gault 1976) at screening
(31) Alanine aminotransferase (ALT) ≥2x the upper limit of normal (ULN) of the performing laboratory, aspartate aminotransferase (AST) ≥2x ULN, total bilirubin ≥1.5x ULN, or alkaline phosphatase (ALP) ≥1.5x ULN at screening
NOTE: Patients with total bilirubin ≥1.5 x ULN are not excluded if they meet all of the following criteria for Gilbert syndrome:
• Bilirubin is predominantly indirect (unconjugated) at screening (direct bilirubin within normal limits)
• Absence of liver disease
• ALT, AST, and ALP ≤1x ULN at screening
• Hemoglobin not significantly decreased at screening
(32) Use of strong inhibitors of CYP3A4 or of strong inducers of CYP3A4 within 30 days before randomization
(33) Use of strong inhibitors of P-glycoprotein (Pgp) or breast cancer resistance protein (BCRP) or inducers of Pgp or sensitive Pgp substrates that may prolong the QT interval within 30 days before randomization
(34) Has any contraindications for MRI studies
Additional exclusion criteria for patients undergoing CSF sampling:
• Has any contraindication for lumbar puncture including clinically significant abnormal findings in laboratory assessments of coagulation or hematology or use of medications known to significantly influence coagulation, such as warfarin or heparin
Additional exclusion criteria for patients using PET for inclusion are as follows:
• Planning to have exposure to ionizing radiation that, in combination with the planned administration of study PET ligand(s), would result in a cumulative exposure that exceeds local recommended exposure limits
• Hypersensitivity to florbetapir F 18
(35) Currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
(36) Previously completed or withdrawn from this study or any other study investigating LY3314814
(37) Treatment with any investigational drug or device within 30 days or 5 half-lives prior to screening (whichever is longer)
(38) Prior treatment with an AD vaccine. Prior treatment with a passive anti-amyloid immunotherapy is allowed if completed at least 5 half-lives prior to randomization.
(39) Investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
(40) Lilly or AstraZeneca employees or employees of any third-party organizations (TPOs) involved in study who require exclusion of their employees, or have caregivers who are Lilly employees or are employees of any TPOs involved in study who required exclusions of their employees
Patients will be excluded from study enrollment if they meet any of the following criteria at screening:
(14) Significant and/or current neurological disease affecting the central nervous system, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, repetitive head trauma, serious infection of the brain, Parkinson’s disease, epilepsy, or cervicocranial vascular disease.
(15) Patients with any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessment, or affect the patient’s ability to complete the study. Patients with history of schizophrenia or other chronic psychosis are excluded.
(16) History of alcohol or drug use disorder (except tobacco use disorder) within 2 years before the screening visit
(17) Within 1 year before the screening visit or between screening and randomization, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptoms of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (such as, significant valvular disease, hypertrophic cardiomyopathy); or hospitalization for arrhythmia
(18) Congenital QT prolongation
(19) Intermittent second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia
(20) A corrected QT (QTcF) interval measurement >470 msec (men and women) at screening (as determined at the investigational site)
(21) History of malignant cancer within the last 5 years
Note: The following is a partial list of conditions that are permissible for study entry: non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical, or non-progressive prostate cancer
(22) Current serious or unstable clinically important systemic illness that, in the judgment of the investigator, is likely to affect cognitive assessment, deteriorate, or affect the patient’s safety or ability to complete the study, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders
(23) History of vitiligo and/or current evidence of post-inflammatory hypopigmentation
(24) Severe drug allergy or anaphylaxis to 2 or more drugs classes
(25) Screening magnetic resonance imaging (MRI) shows evidence of >5 microhemorrhages; prior macrohemorrhage (>1 cm3); ≥4 infarcts, evidence of cerebral contusion, encephalomalacia, space-occupying lesion with mass-effect and edema
Note: Cortical superficial siderosis is not an exclusion.
(26) Uncontrolled hypertension, that is, supine systolic blood pressure >165 mmHg or diastolic blood pressure >95 mmHg. If an initial blood pressure reading is higher than this, an additional attempt (at this visit or on another day) could be used before excluding a patient for uncontrolled hypertension.
(27) Known positive serologic findings for human immunodeficiency virus (HIV) antibodies. Local laws and regulations may apply to whether testing is required.
(28) Patients with past history (suspected or confirmed) of Hepatitis B should have HBsAg testing at screening and are excluded if HBsAg is positive.
Patients with past history (suspected or confirmed) of Hepatitis C (resolved >6 months prior to enrollment) should have hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing at screening and are excluded if HCV RNA PCR is positive.
Patients in high-prevalence regions may be required to have screening serology.
(29) Any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital sign, ECG, or clinical laboratory test results that could be detrimental to the patient or could compromise the study
(30) Calculated creatinine clearance <30 mL/min (Cockcroft-Gault formula; Cockcroft and Gault 1976) at screening
(31) Alanine aminotransferase (ALT) ≥2x the upper limit of normal (ULN) of the performing laboratory, aspartate aminotransferase (AST) ≥2x ULN, total bilirubin ≥1.5x ULN, or alkaline phosphatase (ALP) ≥1.5x ULN at screening
NOTE: Patients with total bilirubin ≥1.5 x ULN are not excluded if they meet all of the following criteria for Gilbert syndrome:
• Bilirubin is predominantly indirect (unconjugated) at screening (direct bilirubin within normal limits)
• Absence of liver disease
• ALT, AST, and ALP ≤1x ULN at screening
• Hemoglobin not significantly decreased at screening
(32) Use of strong inhibitors of CYP3A4 or of strong inducers of CYP3A4 within 30 days before randomization
(33) Use of strong inhibitors of P-glycoprotein (Pgp) or breast cancer resistance protein (BCRP) or inducers of Pgp or sensitive Pgp substrates that may prolong the QT interval within 30 days before randomization
(34) Has any contraindications for MRI studies
Additional exclusion criteria for patients undergoing CSF sampling:
• Has any contraindication for lumbar puncture including clinically significant abnormal findings in laboratory assessments of coagulation or hematology or use of medications known to significantly influence coagulation, such as warfarin or heparin
Additional exclusion criteria for patients using PET for inclusion are as follows:
• Planning to have exposure to ionizing radiation that, in combination with the planned administration of study PET ligand(s), would result in a cumulative exposure that exceeds local recommended exposure limits
• Hypersensitivity to florbetapir F 18
(35) Currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
(36) Previously completed or withdrawn from this study or any other study investigating LY3314814
(37) Treatment with any investigational drug or device within 30 days or 5 half-lives prior to screening (whichever is longer)
(38) Prior treatment with an AD vaccine. Prior treatment with a passive anti-amyloid immunotherapy is allowed if completed at least 5 half-lives prior to randomization.
(39) Investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
(40) Lilly or AstraZeneca employees or employees of any third-party organizations (TPOs) involved in study who require exclusion of their employees, or have caregivers who are Lilly employees or are employees of any TPOs involved in study who required exclusions of their employees
The Estimated Number of Participants
-
Taiwan
80 participants
-
Global
1899 participants
