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Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

NCT ID: NCT02442765

Last Updated: 2023-02-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

387 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-23

Study Completion Date

2019-02-27

Brief Summary

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Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) was to be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association (AA) workgroups.

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Detailed Description

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Eligible participants for this study must have had a diagnosis of probable AD and must have had clinically meaningful agitation secondary to AD.

This was to be a multicenter, randomized, placebo-controlled study, consisting of 12 weeks of treatment.

Approximately 380 participants were to be enrolled at approximately 60 centers in North America.

Study medication was to be administered orally twice-daily from Day 1 through Day 85. Screening was to occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants were to be randomized into the study.

Conditions

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Agitation in Patients With Dementia of the Alzheimer's Type

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Sequential parallel comparison design
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Stage 1: Placebo

Participants received matching placebo orally twice daily (BID) for 6 weeks (Days 1-42) in Stage 1. Participants who completed Stage 1 were eligible to Participate in Stage 2.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Stage 1: AVP-786-18 (d6-DM 18 mg/Q 4.9 mg)

Participants received AVP-786-18 mg orally once daily (QD) in the morning and placebo orally QD in the evening for the first 7 days, followed by AVP-786-18 mg orally BID for the remaining 5 weeks (Days 8-42). Participants who completed Stage 1 were eligible to participate in Stage 2.

Group Type EXPERIMENTAL

AVP-786

Intervention Type DRUG

Stage 1: AVP-786-28 (d6-DM 28 mg/Q 4.9 mg)

Participants received AVP-786-18 mg orally QD in the morning and placebo orally QD in the evening for the first 7 days, followed by AVP-786-18 mg orally BID for 2 weeks (Days 8-21). From Day 22, participants received AVP-786-28 mg orally BID for the remaining 3 weeks. Participants who completed Stage 1 were eligible to participate in Stage 2.

Group Type EXPERIMENTAL

AVP-786

Intervention Type DRUG

Stage 2: Placebo

Participants who received matching placebo orally BID for 6 consecutive weeks in Stage 1 were re-randomized in Stage 2 to receive the study drug or placebo from Day 43 to Day 85.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Stage 1: AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) to: Stage 2: AVP-786-18 (d6-DM 18 mg/Q 4.9 mg)

Participants who received AVP-786-18 mg in Stage 1 continued to receive AVP-786-18 mg orally BID for the 6 weeks (Days 43-85) in Stage 2..

Group Type EXPERIMENTAL

AVP-786

Intervention Type DRUG

Placebo

Intervention Type DRUG

Stage 1: AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) to Stage 2: AVP-786-28 (d6-DM 28 mg/Q 4.9 mg)

Participants who received AVP-786-28 mg in Stage 1 continued to receive AVP-786-28 mg orally BID for 6 weeks (Days 43-85) in Stage 2

Group Type EXPERIMENTAL

AVP-786

Intervention Type DRUG

Placebo

Intervention Type DRUG

Experimental: Stage 1: Placebo to: Stage 2: AVP-786-18 d6-DM 18 mg/Q 4.9 mg

Participants who were placebo responders or non-responders in Stage 1 received AVP-786-18 for 1 week, orally, QD, followed by AVP-786-18 BID for 2 weeks; followed by AVP-786-28 BID for the last 3 weeks.

Group Type EXPERIMENTAL

AVP-786

Intervention Type DRUG

Placebo

Intervention Type DRUG

Stage 1: Placebo to: Stage 2: AVP-786-28 d6 DM 28 mg/Q 4.9 mg

Participants who were placebo responders or non-responders in Stage 1 received AVP-786-28 for 1 week, orally, QD, followed by AVP-786-28 BID for 2 weeks; followed by AVP-786-28 BID for the last 3 weeks.

Group Type EXPERIMENTAL

AVP-786

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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AVP-786

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
* The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
* The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
* Either out patients or residents of an assisted-living facility or a skilled nursing home
* Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation is \>= 4 (moderately ill) at screening and baseline
* Mini-Mental State Examination (MMSE) score is between 6 and 26 (inclusive) at screening and baseline
* Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.

Exclusion Criteria

* Participant has dementia predominantly of non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
* Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
* Participant with myasthenia gravis
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Site

Phoenix, Arizona, United States

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Clinical Research Site

Scottsdale, Arizona, United States

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Clinical Research Site

Little Rock, Arkansas, United States

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Clinical Research Site#1

Irvine, California, United States

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Clinical Research Site#2

Irvine, California, United States

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Clinical Research Site

Long Beach, California, United States

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Clinical Research Site

Oceanside, California, United States

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Clinical Research Site

Orange, California, United States

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Clinical Research Site#1

San Diego, California, United States

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Clinical Research Site#2

San Diego, California, United States

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Clinical Research Site

Santa Ana, California, United States

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Clinical Research Site

Tustin, California, United States

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Denver, Colorado, United States

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Cromwell, Connecticut, United States

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New London, Connecticut, United States

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Norwalk, Connecticut, United States

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Atlantis, Florida, United States

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Clinical Research Site

Boca Raton, Florida, United States

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Clinical Research Site

Brandon, Florida, United States

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Clinical Research Site#1

Coral Gables, Florida, United States

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Clinical Research Site#2

Coral Gables, Florida, United States

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Clinical Research Site#3

Coral Gables, Florida, United States

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Clinical Research Site#1

Deerfield Beach, Florida, United States

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Clinical Research Site

Doral, Florida, United States

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Clinical Research Site

Hialeah, Florida, United States

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Clinical Research Site#1

Hialeah, Florida, United States

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Clinical Research Site#2

Hialeah, Florida, United States

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Clinical Research Site

Jacksonville, Florida, United States

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Clinical Research Site

Kendall, Florida, United States

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Clinical Research Site

Kissimmee, Florida, United States

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Clinical Research Site

Kissimmee, Florida, United States

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Clinical Research Site

Lake Worth, Florida, United States

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Clinical Research Site

Miami, Florida, United States

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Clinical Research Site#1

Miami, Florida, United States

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Clinical Research Site#2

Miami, Florida, United States

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Clinical Research Site

Miami, Florida, United States

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Clinical Research Site

Miami, Florida, United States

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Clinical Research Site#1

Miami, Florida, United States

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Clinical Research Site#2

Miami, Florida, United States

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Clinical Research Site

Miami, Florida, United States

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Clinical Research Site

Miami, Florida, United States

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Clinical Research Site

Miami, Florida, United States

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Clinical Research Site

Miami, Florida, United States

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Clinical Research Site

Miami, Florida, United States

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Clinical Research Site

Miami, Florida, United States

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Clinical Research Site#2

Miami, Florida, United States

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Clinical Research Site

Miami, Florida, United States

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Miami, Florida, United States

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Clinical Research Site

Naples, Florida, United States

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Oakland Park, Florida, United States

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Orlando, Florida, United States

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Ormond Beach, Florida, United States

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Palm Beach Gardens, Florida, United States

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Clinical Research Site

Palmetto Bay, Florida, United States

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Clinical Research Site#2

Pompano Beach, Florida, United States

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Clinical Research Site

Sarasota, Florida, United States

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Clinical Research Site

St. Petersburg, Florida, United States

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Clinical Research Site#1

Tampa, Florida, United States

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Clinical Research Site#2

Tampa, Florida, United States

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Clinical Research Site#2

Tampa, Florida, United States

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Clinical Research Site

Tampa, Florida, United States

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The Villages, Florida, United States

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West Palm Beach, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Newnan, Georgia, United States

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Honolulu, Hawaii, United States

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Schaumburg, Illinois, United States

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Indianapolis, Indiana, United States

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Lenexa, Kansas, United States

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Paducah, Kentucky, United States

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Bedford, Massachusetts, United States

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Quincy, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Paw Paw, Michigan, United States

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Hattiesburg, Mississippi, United States

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Creve Coeur, Missouri, United States

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St Louis, Missouri, United States

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Mount Arlington, New Jersey, United States

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Toms River, New Jersey, United States

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West Long Branch, New Jersey, United States

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Amherst, New York, United States

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Brooklyn, New York, United States

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New York, New York, United States

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New York, New York, United States

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Orangeburg, New York, United States

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Rochester, New York, United States

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Staten Island, New York, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Clinical Research Site

Akron, Ohio, United States

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Clinical Research Site

Cincinnati, Ohio, United States

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Clinical Research Site#1

Columbus, Ohio, United States

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Clinical Research Site#2

Columbus, Ohio, United States

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Clinical Research Site

Dayton, Ohio, United States

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Westerville, Ohio, United States

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Edmond, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Moosic, Pennsylvania, United States

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Willow Grove, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Clinical Research Site

Charleston, South Carolina, United States

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Clinical Research Site#2

Cordova, Tennessee, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Irving, Texas, United States

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Mansfield, Texas, United States

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Clinton, Utah, United States

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Clinical Research Site

Woodstock, Vermont, United States

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Clinical Research Site#1

Tallinn, , Estonia

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Clinical Research Site#2

Tallinn, , Estonia

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Clinical Research Site

Tartu, , Estonia

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Clinical Research Site

Mittweida, , Germany

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Clinical Research Site

Lublin, Lublin Voivodeship, Poland

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Clinical Research Site

Bydgoszcz, , Poland

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Kielce, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Pruszcz Gdański, , Poland

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Siemianowice Śląskie, , Poland

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Torres Vedras, , Portugal

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Clinical Research Site

Bayamón, , Puerto Rico

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Clinical Research Site

San Juan, , Puerto Rico

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Countries

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United States Estonia Germany Poland Portugal Puerto Rico

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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15-AVP-786-301

Identifier Type: -

Identifier Source: org_study_id

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