Indian Phenotype Registry (IP Registry)

June 12, 2020 updated by: AstraZeneca

A Non-interventional Nationwide Registry to Identify Indian Phenotype Characteristics in Diabetes Mellitus Patients in India.

This study is a non-interventional, multicentre observational study to be conducted at 1000 sites in India. The study targets to enrol approx. 50000 patients with approx. 50 patients per site. The study would enrol Diabetes Mellitus patients who provides written informed consent. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice will be screened for enrolment in study. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).

Study Overview

Status

Completed

Conditions

Detailed Description

This study is a non-interventional, multicentre observational study to be conducted at 1000 sites in India. The study targets to enrol approx. 50000 patients with approx. 50 patients per site. The study would enrol Diabetes Mellitus patients who provides written informed consent. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice will be screened for enrolment in study. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).

This is a single visit cross sectional study however during site feasibility visit, probability of follow-up of these patients will be evaluated. If feasible protocol will be amended to continue data collection prospectively for appropriate duration

Study Type

Observational

Enrollment (Actual)

40000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Chandigarh, India, D1843R00282
        • Research Site
      • Goa, India, D1843R00282
        • Research Site
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, India, D1843R00282
        • Research Site
      • Kakinada, Andhra Pradesh, India, D1843R00282
        • Research Site
      • Madanapalle, Andhra Pradesh, India, D1843R00282
        • Research Site
      • Nellore, Andhra Pradesh, India, D1843R00282
        • Research Site
      • Rajahmundry, Andhra Pradesh, India, D1843R00282
        • Research Site
      • Vijaywada, Andhra Pradesh, India, D1843R00282
        • Research Site
      • Visakhapatnam, Andhra Pradesh, India, D1843R00282
        • Research Site
    • Assam
      • Dibrugarh, Assam, India, D1843R00282
        • Research Site
      • Guwahati, Assam, India, D1843R00282
        • Research Site
      • Nagaon, Assam, India, D1843R00282
        • Research Site
      • Silchar, Assam, India, D1843R00282
        • Research Site
      • Tinsukia, Assam, India, D1843R00282
        • Research Site
    • Bihar
      • Bhagalpur, Bihar, India, D1843R00282
        • Research Site
      • Gaya, Bihar, India, D1843R00282
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      • Patna, Bihar, India, D1843R00282
        • Research Site
      • Samastipur, Bihar, India, D1843R00282
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      • Samstipur, Bihar, India, D1843R00282
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    • Chhattisgarh
      • Bhilai, Chhattisgarh, India, D1843R00282
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      • Durg, Chhattisgarh, India, D1843R00282
        • Research Site
      • Raipur, Chhattisgarh, India, D1843R00282
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      • Rohtak, Chhattisgarh, India, D1843R00282
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    • Delhi
      • New Delhi, Delhi, India, D1843R00282
        • Research Site
    • Gujarat
      • Ahmedabad, Gujarat, India, D1843R00282
        • Research Site
      • Amreli, Gujarat, India, D1843R00282
        • Research Site
      • Anand, Gujarat, India, D1843R00282
        • Research Site
      • Bharuch, Gujarat, India, D1843R00282
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      • Bhavnagar, Gujarat, India, D1843R00282
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      • Bhuj, Gujarat, India, D1843R00282
        • Research Site
      • Borsad, Gujarat, India, D1843R00282
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      • Botad, Gujarat, India, D1843R00282
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      • Chaibasa, Gujarat, India, D1843R00282
        • Research Site
      • Dahod, Gujarat, India, D1843R00282
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      • Himatnagar, Gujarat, India, D1843R00282
        • Research Site
      • Jamnagar, Gujarat, India, D1843R00282
        • Research Site
      • Junagadh, Gujarat, India, D1843R00282
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      • Kutch, Gujarat, India, D1843R00282
        • Research Site
      • Morbi, Gujarat, India, D1843R00282
        • Research Site
      • Nadiad, Gujarat, India, D1843R00282
        • Research Site
      • Navsari, Gujarat, India, D1843R00282
        • Research Site
      • Patan, Gujarat, India, D1843R00282
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      • Porbandar, Gujarat, India, D1843R00282
        • Research Site
      • Rajkot, Gujarat, India, D1843R00282
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      • Surat, Gujarat, India, D1843R00282
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      • Unnao, Gujarat, India, D1843R00282
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      • Vadodara, Gujarat, India, D1843R00282
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      • Valsad, Gujarat, India, D1843R00282
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      • Vapi, Gujarat, India, D1843R00282
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    • Haryana
      • Bangalore, Haryana, India, D1843R00282
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      • Faridabad, Haryana, India, D1843R00282
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      • Gurugram, Haryana, India, D1843R00282
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      • Hisar, Haryana, India, D1843R00282
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      • Panchkula, Haryana, India, D1843R00282
        • Research Site
      • Panipat, Haryana, India, D1843R00282
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      • Rohtak, Haryana, India, D1843R00282
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      • Sonipat, Haryana, India, D1843R00282
        • Research Site
      • Yamunanagar, Haryana, India, D1843R00282
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    • Himachal Pradesh
      • Mandi, Himachal Pradesh, India, D1843R00282
        • Research Site
    • Jammu And Kashmir
      • Srinagar, Jammu And Kashmir, India, D1843R00282
        • Research Site
    • Jharkhand
      • Jamshedpur, Jharkhand, India, D1843R00282
        • Research Site
      • Ranchi, Jharkhand, India, D1843R00282
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    • Karnataka
      • Bangalore, Karnataka, India, D1843R00282
        • Research Site
      • Belgaum, Karnataka, India, D1843R00282
        • Research Site
      • Gulbarga, Karnataka, India, D1843R00282
        • Research Site
    • Kerala
      • Angamaly, Kerala, India, D1843R00282
        • Research Site
      • Chengannur, Kerala, India, D1843R00282
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      • Edappally, Kerala, India, D1843R00282
        • Research Site
      • Ernakulam, Kerala, India, D1843R00282
        • Research Site
      • Idukki, Kerala, India, D1843R00282
        • Research Site
      • Kochi, Kerala, India, D1843R00282
        • Research Site
      • Kollam, Kerala, India, D1843R00282
        • Research Site
      • Kottayam, Kerala, India, D1843R00282
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      • Malappuram, Kerala, India, D1843R00282
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      • Nedumangad, Kerala, India, D1843R00282
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      • Palakkad, Kerala, India, D1843R00282
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      • Pezhakkappilly, Kerala, India, D1843R00282
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      • Thalassery, Kerala, India, D1843R00282
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      • Thiruvananthapuram, Kerala, India, D1843R00282
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      • Thrissur, Kerala, India, D1843R00282
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      • Trivandrum, Kerala, India, D1843R00282
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    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, India, D1843R00282
        • Research Site
      • Guna, Madhya Pradesh, India, D1843R00282
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      • Gwalior, Madhya Pradesh, India, D1843R00282
        • Research Site
      • Indore, Madhya Pradesh, India, D1843R00282
        • Research Site
      • Jabalpur, Madhya Pradesh, India, D1843R00282
        • Research Site
      • Mandsaur, Madhya Pradesh, India, D1843R00282
        • Research Site
      • Ujjain, Madhya Pradesh, India, D1843R00282
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    • Maharastra
      • Ahmednagar, Maharastra, India, D1843R00282
        • Research Site
      • Aurangabad, Maharastra, India, D1843R00282
        • Research Site
      • Bhiwandi, Maharastra, India, D1843R00282
        • Research Site
      • Kalyan, Maharastra, India, D1843R00282
        • Research Site
      • Kolhapur, Maharastra, India, D1843R00282
        • Research Site
      • Mumbai, Maharastra, India, D1843R00282
        • Research Site
      • Nagpur, Maharastra, India, D1843R00282
        • Research Site
      • Nasik, Maharastra, India, D1843R00282
        • Research Site
      • Navi Mumbai, Maharastra, India, D1843R00282
        • Research Site
      • Palanpur, Maharastra, India, D1843R00282
        • Research Site
      • Palghar, Maharastra, India, D1843R00282
        • Research Site
      • Pune, Maharastra, India, D1843R00282
        • Research Site
      • Raigad, Maharastra, India, D1843R00282
        • Research Site
      • Rajkot, Maharastra, India, D1843R00282
        • Research Site
      • Sangli, Maharastra, India, D1843R00282
        • Research Site
      • Satara, Maharastra, India, D1843R00282
        • Research Site
      • Sindhudurg, Maharastra, India, D1843R00282
        • Research Site
      • Solapur, Maharastra, India, D1843R00282
        • Research Site
      • Thane, Maharastra, India, D1843R00282
        • Research Site
      • Vasai, Maharastra, India, D1843R00282
        • Research Site
    • Manipur
      • Imphal, Manipur, India, D1843R00282
        • Research Site
    • Meghalaya
      • Shillong, Meghalaya, India, D1843R00282
        • Research Site
    • Odisha
      • Berhampur, Odisha, India, D1843R00282
        • Research Site
      • Bhubaneswar, Odisha, India, D1843R00282
        • Research Site
      • Bhubneshwar, Odisha, India, D1843R00282
        • Research Site
      • Bhuvaneshwar, Odisha, India, D1843R00282
        • Research Site
      • Cuttack, Odisha, India, D1843R00282
        • Research Site
      • Cuttuck, Odisha, India, D1843R00282
        • Research Site
      • Paradip, Odisha, India, D1843R00282
        • Research Site
      • Puri, Odisha, India, D1843R00282
        • Research Site
      • Rourkela, Odisha, India, D1843R00282
        • Research Site
      • Sambalpur, Odisha, India, D1843R00282
        • Research Site
    • Panjab
      • Amritsar, Panjab, India, D1843R00282
        • Research Site
      • Jalandhar, Panjab, India, D1843R00282
        • Research Site
      • Khanna, Panjab, India, D1843R00282
        • Research Site
      • Kharar, Panjab, India, D1843R00282
        • Research Site
      • Ludhiana, Panjab, India, D1843R00282
        • Research Site
      • Moga, Panjab, India, D1843R00282
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      • Patiala, Panjab, India, D1843R00282
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    • Rajasthan
      • Ajmer, Rajasthan, India, D1843R00282
        • Research Site
      • Ambala, Rajasthan, India, D1843R00282
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      • Bikaner, Rajasthan, India, D1843R00282
        • Research Site
      • Hanumangarh, Rajasthan, India, D1843R00282
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      • Jaipur, Rajasthan, India, D1843R00282
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      • Jamshedpur, Rajasthan, India, D1843R00282
        • Research Site
      • Jodhpur, Rajasthan, India, D1843R00282
        • Research Site
      • Kota, Rajasthan, India, D1843R00282
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      • Udaipur, Rajasthan, India, D1843R00282
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    • Tamil Nadu
      • Chennai, Tamil Nadu, India, D1843R00282
        • Research Site
      • Coimbatore, Tamil Nadu, India, D1843R00282
        • Research Site
      • Erode, Tamil Nadu, India, D1843R00282
        • Research Site
      • Hosur, Tamil Nadu, India, D1843R00282
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      • Kanchipuram, Tamil Nadu, India, D1843R00282
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      • Kochi, Tamil Nadu, India, D1843R00282
        • Research Site
      • Kumbakonam, Tamil Nadu, India, D1843R00282
        • Research Site
      • Madurai, Tamil Nadu, India, D1843R00282
        • Research Site
      • Nagerkoil, Tamil Nadu, India, D1843R00282
        • Research Site
      • Pattukottai, Tamil Nadu, India, D1843R00282
        • Research Site
      • Pondicherry, Tamil Nadu, India, D1843R00282
        • Research Site
      • Ranipet, Tamil Nadu, India, D1843R00282
        • Research Site
      • Salem, Tamil Nadu, India, D1843R00282
        • Research Site
      • Thanjavur, Tamil Nadu, India, D1843R00282
        • Research Site
      • Thiruvannamalai, Tamil Nadu, India, D1843R00282
        • Research Site
      • Thiruvarur, Tamil Nadu, India, D1843R00282
        • Research Site
      • Trichy, Tamil Nadu, India, D1843R00282
        • Research Site
      • Vellore, Tamil Nadu, India, D1843R00282
        • Research Site
    • Telangana
      • Hyderabad, Telangana, India, D1843R00282
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      • Karimnagar, Telangana, India, D1843R00282
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      • Secunderabad, Telangana, India, D1843R00282
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    • Uttar Pradesh
      • Agra, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Aligarh, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Allahabad, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Bareilly, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Bareli, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Bulandshahr, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Etawah, Uttar Pradesh, India, D1843R00282
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      • Faizabad, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Firozabad, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Ghaziabad, Uttar Pradesh, India, D1843R00282
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      • Gorakhpur, Uttar Pradesh, India, D1843R00282
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      • Hathras, Uttar Pradesh, India, D1843R00282
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      • Jhansi, Uttar Pradesh, India, D1843R00282
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      • Kanpur, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Karnal, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Lucknow, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Meerut, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Moradabad, Uttar Pradesh, India, D1843R00282
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      • Noida, Uttar Pradesh, India, D1843R00282
        • Research Site
      • Piliphit, Uttar Pradesh, India, D1843R00282
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      • Rampur, Uttar Pradesh, India, D1843R00282
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      • Varanasi, Uttar Pradesh, India, D1843R00282
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    • Uttarakhand
      • Dehradun, Uttarakhand, India, D1843R00282
        • Research Site
      • Haldwani, Uttarakhand, India, D1843R00282
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    • West Bengal
      • Baguihati, West Bengal, India, D1843R00282
        • Research Site
      • Basirhat, West Bengal, India, D1843R00282
        • Research Site
      • Bolapur, West Bengal, India, D1843R00282
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      • Burdwan, West Bengal, India, D1843R00282
        • Research Site
      • Durgapur, West Bengal, India, D1843R00282
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      • Guwahati, West Bengal, India, D1843R00282
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      • Habra, West Bengal, India, D1843R00282
        • Research Site
      • Hooghly, West Bengal, India, D1843R00282
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      • Howrah, West Bengal, India, D1843R00282
        • Research Site
      • Hubli, West Bengal, India, D1843R00282
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      • Jalpaiguri, West Bengal, India, D1843R00282
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      • Kharagpur, West Bengal, India, D1843R00282
        • Research Site
      • Kolkata, West Bengal, India, D1843R00282
        • Research Site
      • Malda, West Bengal, India, D1843R00282
        • Research Site
      • Nadia, West Bengal, India, D1843R00282
        • Research Site
      • Siliguri, West Bengal, India, D1843R00282
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetes Mellitus patients

Description

Inclusion Criteria

  1. Male or female patients with 18 years and above.
  2. Patients who provide written informed consent.
  3. Patients with previously diagnosed with Diabetes Mellitus
  4. HbA1C report available within past 3 months

Exclusion Criteria- None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Diabetes Mellitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate total body fat content across various BMI categories in the study population
Time Frame: 1 day

Bioelectrical impedance will be used to estimate how much % body fat in terms of weight compared to total body weight.

Since it is a ratio (weight of fat/total body weight) so no unit is required. The ratio will be multiplied by 100 to get Fat percentage.

1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To analyse different characteristics of Diabetes Mellitus patient in study population
Time Frame: 1 day
patient characteristics like age, gender
1 day
To correlate HbA1C level with various BMI categories
Time Frame: 1 day
Weight in kilogram, height in meter will be combined to report BMI in kg/m2. then HbA1c in percentage and BMI in kg/m2 will be aggregated to get correlation
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2017

Primary Completion (Actual)

June 14, 2019

Study Completion (Actual)

June 14, 2019

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

November 30, 2017

First Posted (Actual)

December 6, 2017

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D1843R00282

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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