American College of Clinical Pharmacology

American College of Clinical Pharmacology

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Register Now for the ACCP Clinical Practice Webinar: Clinical Pharmacology of Non-opioid Analgesia

May 19th | 2:00 PM ET | 1.5 CME/CPE credits
Registration is free! https://bit.ly/3D1VM26

Speaker: Dr. Claude Abdallah, Anesthesiologist, Pediatric, Children's Nat'l Health System
The US #FDA #CDER Div of Pediatrics & Maternal Health in the #OND and the Office of Clinical Pharmacology in the #OTS as well as the #MCERSI will hold a two-day virtual public workshop entitled "Pharmacokinetic Evaluation in Pregnancy." For more info: https://bit.ly/3K5cIr8
The US #FDA announced the availability of a final guidance for industry entitled #Bioavailability Studies Submitted in #NDAs or #INDs - General Considerations. For more information please visit: https://bit.ly/3jTnp5y
‼️ It's not too late to register for the #Students, #Trainees & Early-stage Professionals Webinar: "Lead the Way-With the Next STEP in Your #Career".

Tomorrow, Apr 20th, at 12:30 PM ET. Secure your spot today! https://bit.ly/3KNttZo

We look forward to seeing you then!
Thank you to all of our Volunteers! We sincerely appreciate your time and support of ACCP. We couldn't do it without you!
#NationalVolunteerWeek
➡️ Today is the Deadline to Submit Your Abstract for the #2022ACCP Annual Meeting, Sept 25 - 27, 2022 in Bethesda, MD.

Please submit your Abstract by 11:59 PM ET. We look forward to your submission! https://bit.ly/3b2OTzZ
#pharmacology #abstracts #annualmeeting
The US #FDA approved #VIJOICE (#alpelisib) for the treatment of adult & pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (#PROS) who require systemic therapy.

Learn more: https://bit.ly/3KOvFQc
ACCP is pleased to announce Dr. Andrea Edginton as the recipient of the 2022 Roger Jelliffe Individualized Therapy Award.

Congratulations, Dr. Edginton!
#2022ACCP
❗ Only One Week Until the #Students, #Trainees & Early-stage Professionals Webinar: "Lead the Way-With the Next STEP in Your #Career" | Apr 20th | 12:30 PM ET

Secure your spot today! https://bit.ly/3ujrkxr

Join us to...
- Learn how to establish a network that supports your career over time;
- Understand the importance of developing a team of mentors to support your career growth;
- Recognize the opportunities to develop skills that foster academic excellence by participation in ACCP-sponsored events;
- Learn how to build leadership skills and influence without authority.

We look forward to your participation!
Clinical Pharmacology in Drug Development, April 2022 Volume 11, Issue 4 is now available! https://bit.ly/39XjxMS
#pharmacology #drugdevelopment

*Articles*
Drug‐Drug Interaction of Letermovir and Atorvastatin in Healthy Participants
Jacqueline B. McCrea, Karsten Menzel, Adedayo Adedoyin, Carolyn R. Cho, Sabrina Fox-Bosetti, Sreeraj Macha, Tian Zhao, Fang Liu, Deborah Panebianco, S. Aubrey Stoch, Marian Iwamoto
Pages: 420-428 | First Published: 14 February 2022

Pharmacokinetic/Pharmacodynamic Evaluation of Ivosidenib or Enasidenib Combined With Intensive Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed IDH1/2‐Mutant Acute Myeloid Leukemia
Bin Fan, Yue Chen, Feng Yin, Lei Hua, Caroline Almon, Salah Nabhan, Michael Cooper, Hua Yang, Mohammad Hossain
Pages: 429-441 | First Published: 14 February 2022

Lack of Electrocardiographic Effects of Deucravacitinib in Healthy Subjects
Anjaneya Chimalakonda, Shalabh Singhal, Raymond Darbenzio, Randy Dockens, David Marchisin, Subhashis Banerjee, Ihab G. Girgis, John Throup, Bing He, Urvi Aras, Bindu Murthy
Pages: 442-453 | First Published: 19 February 2022

Population Pharmacokinetics Analysis of Pemigatinib in Patients With Advanced Malignancies
Tao Ji, Xuejun Chen, Xiang Liu, Swamy Yeleswaram
Pages: 454-466 | First Published: 29 January 2022

Pharmacokinetics and Safety of the Nucleoside Analog Antiviral Drug Galidesivir Administered to Healthy Adult Subjects
Amanda Mathis, David Collins, Sylvia Dobo, Dennis M. Walling, William P. Sheridan, Ray Taylor
Pages: 467-474 | First Published: 19 February 2022

Effect of Phosphate Binders and a Dietary Iron Supplement on the Pharmacokinetics of a Single Dose of Vadadustat in Healthy Adults
Susan K. Paulson, Jimena Martinez, Rishikesh Sawant, Steven K. Burke, Ajit Chavan
Pages: 475-485 | First Published: 16 February 2022

Effect of Roxadustat on the Pharmacokinetics of Simvastatin, Rosuvastatin, and Atorvastatin in Healthy Subjects: Results From 3 Phase 1, Open‐Label, 1‐Sequence, Crossover Studies
Dorien Groenendaal-van de Meent, Martin den Adel, Virginie Kerbusch, Jan van Dijk, Tomohisa Shibata, Kota Kato, Marloes Schaddelee
Pages: 486-501 | First Published: 19 February 2022

Pharmacokinetics and Pharmacodynamics of Repository Corticotropin Injection Compared With Synthetic ACTH1‐24 Depot and Methylprednisolone in Healthy Subjects
Nagaraju Poola, Bryan Due, Dale Wright, Leah R. Brooks, Fahima Zaman
Pages: 502-515 | First Published: 15 September 2021

Pharmacokinetics and Bioequivalence of a Generic and a Branded Budesonide Nasal Spray in Healthy Chinese Subjects
Xin Li, Yuan Li, Bing Xu, Ping Zhang, Yangyang Wang, Zhenyu Wang, Shuguang Hou
Pages: 516-522 | First Published: 16 November 2021

A Phase 1 Clinical Study Evaluating the Effects of Cenobamate on the QT Interval
Borje Darpo, Philip T. Sager, Hongqi Xue, Marc Kamin
Pages: 523-534 | First Published: 19 February 2022

Clinical Pharmacokinetics and Safety of a 10% Aminolevulinic Acid Hydrochloride Nanoemulsion Gel (BF‐200 ALA) in Photodynamic Therapy of Patients Extensively Affected With Actinic Keratosis: Results of 2 Maximal Usage Pharmacokinetic Trials
Ben Novak, Janet DuBois, Osama Chahrour, Tamara Papusha, Stefan Hirt, Thomas Philippi, Corinna Zogel, Katharina Osenberg, Beate Schmitz, Hermann Lübbert
Pages: 535-550 | First Published: 11 October 2021

Bioequivalence and Pharmacokinetic Evaluation of 2 Pyrazinamide Formulations in Healthy Chinese Adults: A Single‐Dose, Open‐Label, Randomized‐Sequence, 2×2 Crossover Study
Siyang Wang, Jian Ren, Hongxia Wang, Tingting Zhi, Yuanyuan Zhu, Jinxin Feng, Zhen Li, Ruiqin Zhang
Pages: 551-556 | First Published:16 November 2021
Registration is now open for the #2022ACCP Annual Meeting!

Please join us live and in-person September 25th – 27th for "Transforming Global Health through Clinical Pharmacology".

The 3-day meeting includes:

• 14 Outstanding educational Symposia, two Hot Topic Sessions and a Plenary Session
• Invited Keynote: Nora D. Volkow, MD, Director, National Inst on Drug Abuse, National Inst of Health will present on "The Increasing Complexity of Substance Use Disorders that Impact the Lives of Millions"
• 2022 Trends in Drug Development Seminar on cutting-edge topics in preclinical and clinical drug development
• Pre-meeting Workshop on Quantitative Systems Pharmacology
• A series of events for Students, Trainees & Early-stage Professionals
• 2022 ACCP Recognition Award Winner presentations & interviews during lunch
• Evening receptions on Sunday and Monday where Attendees can socialize & network, explore scientific Posters and meet with our valued Exhibitors.

Early Bird registration ends June 30th, reserve your seat today! https://bit.ly/2NJzUjG
#pharmacology #CME #CPE #annualmeeting

American College of Clinical Pharmacology (ACCP) is a non-profit membership association with a 40+ year history of providing exceptional interdisciplinary,

Founded in 1969 by a group of eminent physicians, the College today consists of a full spectrum of healthcare professionals who remain dedicated to advancing clinical pharmacology with the goal of providing exceptional patient care. As an organization whose primary role is education, the College does not concentrate on any one aspect of the discipline. Rather, the College seeks to address the edu

Operating as usual

Timeline photos 04/21/2022

Register Now for the ACCP Clinical Practice Webinar: Clinical Pharmacology of Non-opioid Analgesia

May 19th | 2:00 PM ET | 1.5 CME/CPE credits
Registration is free! https://bit.ly/3D1VM26

Speaker: Dr. Claude Abdallah, Anesthesiologist, Pediatric, Children's Nat'l Health System

Pharmacokinetic Evaluation in Pregnancy- VIRTUAL PUBLIC WORKSHOP 04/21/2022

Pharmacokinetic Evaluation in Pregnancy- VIRTUAL PUBLIC WORKSHOP

The US #FDA #CDER Div of Pediatrics & Maternal Health in the #OND and the Office of Clinical Pharmacology in the #OTS as well as the #MCERSI will hold a two-day virtual public workshop entitled "Pharmacokinetic Evaluation in Pregnancy." For more info: https://bit.ly/3K5cIr8

Pharmacokinetic Evaluation in Pregnancy- VIRTUAL PUBLIC WORKSHOP Pharmacokinetic Evaluation in Pregnancy- VIRTUAL PUBLIC WORKSHOP

Bioavailability Studies Submitted in NDAs or INDs 04/20/2022

Bioavailability Studies Submitted in NDAs or INDs

The US #FDA announced the availability of a final guidance for industry entitled #Bioavailability Studies Submitted in #NDAs or #INDs - General Considerations. For more information please visit: https://bit.ly/3jTnp5y

Bioavailability Studies Submitted in NDAs or INDs Bioavailability Studies Submitted in NDAs or INDs – General Considerations

Timeline photos 04/19/2022

‼️ It's not too late to register for the #Students, #Trainees & Early-stage Professionals Webinar: "Lead the Way-With the Next STEP in Your #Career".

Tomorrow, Apr 20th, at 12:30 PM ET. Secure your spot today! https://bit.ly/3KNttZo

We look forward to seeing you then!

Timeline photos 04/18/2022

Thank you to all of our Volunteers! We sincerely appreciate your time and support of ACCP. We couldn't do it without you!
#NationalVolunteerWeek

Timeline photos 04/18/2022

➡️ Today is the Deadline to Submit Your Abstract for the #2022ACCP Annual Meeting, Sept 25 - 27, 2022 in Bethesda, MD.

Please submit your Abstract by 11:59 PM ET. We look forward to your submission! https://bit.ly/3b2OTzZ
#pharmacology #abstracts #annualmeeting

04/15/2022

www.accessdata.fda.gov

The US #FDA approved #VIJOICE (#alpelisib) for the treatment of adult & pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (#PROS) who require systemic therapy.

Learn more: https://bit.ly/3KOvFQc

www.accessdata.fda.gov

Timeline photos 04/13/2022

❗ Only One Week Until the #Students, #Trainees & Early-stage Professionals Webinar: "Lead the Way-With the Next STEP in Your #Career" | Apr 20th | 12:30 PM ET

Secure your spot today! https://bit.ly/3ujrkxr

Join us to...
- Learn how to establish a network that supports your career over time;
- Understand the importance of developing a team of mentors to support your career growth;
- Recognize the opportunities to develop skills that foster academic excellence by participation in ACCP-sponsored events;
- Learn how to build leadership skills and influence without authority.

We look forward to your participation!

Timeline photos 04/13/2022

Clinical Pharmacology in Drug Development, April 2022 Volume 11, Issue 4 is now available! https://bit.ly/39XjxMS
#pharmacology #drugdevelopment

*Articles*
Drug‐Drug Interaction of Letermovir and Atorvastatin in Healthy Participants
Jacqueline B. McCrea, Karsten Menzel, Adedayo Adedoyin, Carolyn R. Cho, Sabrina Fox-Bosetti, Sreeraj Macha, Tian Zhao, Fang Liu, Deborah Panebianco, S. Aubrey Stoch, Marian Iwamoto
Pages: 420-428 | First Published: 14 February 2022

Pharmacokinetic/Pharmacodynamic Evaluation of Ivosidenib or Enasidenib Combined With Intensive Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed IDH1/2‐Mutant Acute Myeloid Leukemia
Bin Fan, Yue Chen, Feng Yin, Lei Hua, Caroline Almon, Salah Nabhan, Michael Cooper, Hua Yang, Mohammad Hossain
Pages: 429-441 | First Published: 14 February 2022

Lack of Electrocardiographic Effects of Deucravacitinib in Healthy Subjects
Anjaneya Chimalakonda, Shalabh Singhal, Raymond Darbenzio, Randy Dockens, David Marchisin, Subhashis Banerjee, Ihab G. Girgis, John Throup, Bing He, Urvi Aras, Bindu Murthy
Pages: 442-453 | First Published: 19 February 2022

Population Pharmacokinetics Analysis of Pemigatinib in Patients With Advanced Malignancies
Tao Ji, Xuejun Chen, Xiang Liu, Swamy Yeleswaram
Pages: 454-466 | First Published: 29 January 2022

Pharmacokinetics and Safety of the Nucleoside Analog Antiviral Drug Galidesivir Administered to Healthy Adult Subjects
Amanda Mathis, David Collins, Sylvia Dobo, Dennis M. Walling, William P. Sheridan, Ray Taylor
Pages: 467-474 | First Published: 19 February 2022

Effect of Phosphate Binders and a Dietary Iron Supplement on the Pharmacokinetics of a Single Dose of Vadadustat in Healthy Adults
Susan K. Paulson, Jimena Martinez, Rishikesh Sawant, Steven K. Burke, Ajit Chavan
Pages: 475-485 | First Published: 16 February 2022

Effect of Roxadustat on the Pharmacokinetics of Simvastatin, Rosuvastatin, and Atorvastatin in Healthy Subjects: Results From 3 Phase 1, Open‐Label, 1‐Sequence, Crossover Studies
Dorien Groenendaal-van de Meent, Martin den Adel, Virginie Kerbusch, Jan van Dijk, Tomohisa Shibata, Kota Kato, Marloes Schaddelee
Pages: 486-501 | First Published: 19 February 2022

Pharmacokinetics and Pharmacodynamics of Repository Corticotropin Injection Compared With Synthetic ACTH1‐24 Depot and Methylprednisolone in Healthy Subjects
Nagaraju Poola, Bryan Due, Dale Wright, Leah R. Brooks, Fahima Zaman
Pages: 502-515 | First Published: 15 September 2021

Pharmacokinetics and Bioequivalence of a Generic and a Branded Budesonide Nasal Spray in Healthy Chinese Subjects
Xin Li, Yuan Li, Bing Xu, Ping Zhang, Yangyang Wang, Zhenyu Wang, Shuguang Hou
Pages: 516-522 | First Published: 16 November 2021

A Phase 1 Clinical Study Evaluating the Effects of Cenobamate on the QT Interval
Borje Darpo, Philip T. Sager, Hongqi Xue, Marc Kamin
Pages: 523-534 | First Published: 19 February 2022

Clinical Pharmacokinetics and Safety of a 10% Aminolevulinic Acid Hydrochloride Nanoemulsion Gel (BF‐200 ALA) in Photodynamic Therapy of Patients Extensively Affected With Actinic Keratosis: Results of 2 Maximal Usage Pharmacokinetic Trials
Ben Novak, Janet DuBois, Osama Chahrour, Tamara Papusha, Stefan Hirt, Thomas Philippi, Corinna Zogel, Katharina Osenberg, Beate Schmitz, Hermann Lübbert
Pages: 535-550 | First Published: 11 October 2021

Bioequivalence and Pharmacokinetic Evaluation of 2 Pyrazinamide Formulations in Healthy Chinese Adults: A Single‐Dose, Open‐Label, Randomized‐Sequence, 2×2 Crossover Study
Siyang Wang, Jian Ren, Hongxia Wang, Tingting Zhi, Yuanyuan Zhu, Jinxin Feng, Zhen Li, Ruiqin Zhang
Pages: 551-556 | First Published:16 November 2021

Timeline photos 04/12/2022

Registration is now open for the #2022ACCP Annual Meeting!

Please join us live and in-person September 25th – 27th for "Transforming Global Health through Clinical Pharmacology".

The 3-day meeting includes:

• 14 Outstanding educational Symposia, two Hot Topic Sessions and a Plenary Session
• Invited Keynote: Nora D. Volkow, MD, Director, National Inst on Drug Abuse, National Inst of Health will present on "The Increasing Complexity of Substance Use Disorders that Impact the Lives of Millions"
• 2022 Trends in Drug Development Seminar on cutting-edge topics in preclinical and clinical drug development
• Pre-meeting Workshop on Quantitative Systems Pharmacology
• A series of events for Students, Trainees & Early-stage Professionals
• 2022 ACCP Recognition Award Winner presentations & interviews during lunch
• Evening receptions on Sunday and Monday where Attendees can socialize & network, explore scientific Posters and meet with our valued Exhibitors.

Early Bird registration ends June 30th, reserve your seat today! https://bit.ly/2NJzUjG
#pharmacology #CME #CPE #annualmeeting

Timeline photos 04/08/2022

⏳ Only 10 Days Until the Apr 18th Deadline to Submit Your Abstract for the #2022ACCP Annual Mtg, Sept 25 - 27, 2022.

Please review the Areas of Abstract Submission & Guidelines: https://bit.ly/3b2OTzZ.
We look forward to your submission!
#pharmacology #abstracts #annualmeeting

Timeline photos 04/07/2022

ACCP is pleased to announce Dr. Honghui Zhou as the recipient of the #2022ACCP Nathaniel T. Kwit Memorial Distinguished Service Award.

Congratulations, Dr. Zhou!

04/05/2022

www.accessdata.fda.gov

The US #FDA approved #OPDUALAG for the treatment of #unresectable or #metastatic #melanoma in patients 12 years or older. Prescribing info can be found here: https://bit.ly/3LK2yh6

www.accessdata.fda.gov

Timeline photos 04/05/2022

The Journal of Clinical Pharmacology - April 2022, Vol 62, Issue 4 is now available!
https://bit.ly/34k1K1Z

*Editor's Choice: Review*
Pain Management Considerations in Patients With Opioid Use Disorder Requiring Critical Care
Kathryn Smith PharmD, BCPS, BCCCP, Michelle Wang PharmD, Ruslan Abdukalikov DO, Amy McAullife PMH-NP, BC, Dena Whitesell MD, Janelle Richard BA, CCRP, William Sauer MD, Aurora Quaye MD
Pages: 449-462 | First Published: 14 November 2021

*Continuing Education: Review*
MDMA‐Assisted Psychotherapy for Treatment of Posttraumatic Stress Disorder: A Systematic Review With Meta‐Analysis
Kimberly W. Smith PharmD, Dakota J. Sicignano, Adrian V. Hernandez MD, PhD, C. Michael White PharmD, FCP, FCCP
Pages: 463-471 | First Published: 28 October 2021

*Therapeutic Drug Monitoring*
Long‐Acting Lipoglycopeptides Can Interfere With Vancomycin Therapeutic Drug Monitoring
Dan F. Smelter PhD, Michael J. Trisler PharmD, MPH, Erin K. McCreary PharmD, Matthew Baker BS, Kenneth Copeland PhD, Thomas J. Dilworth PharmD, Warren E. Rose PharmD, MPH
Pages: 472-478 | First Published: 26 September 2021

*Therapeutics*
Time Above All Else: Pharmacodynamic Analysis of β‐Lactams in Critically Ill Patients
Katie B. Landmesser PharmD, Justin A. Clark PharmD, MS, David S. Burgess PharmD, FCCP, FIDP
Pages: 479-485 | First Published: 06 October 2021

*Regulatory Science*
Racial and Ethnic Differences in Drug Disposition and Response: Review of New Molecular Entities Approved Between 2014 and 2019
Anuradha Ramamoorthy PhD, FCP, Hannah H. Kim BS, Ebony Shah-Williams PhD, Lei Zhang PhD
Pages: 486-493 | First Published: 04 October 2021

*Drug Interactions*
Assessment of Transporter‐Mediated Drug Interactions for Enasidenib Based on a Cocktail Study in Patients With Relapse or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Yiming Cheng PhD, Xiaomin Wang PhD, Zeen Tong PhD, Josephine Reyes PhD, Leon Carayannopoulos MD, PhD, Simon Zhou PhD, Yan Li PhD
Pages: 494-504 | First Published: 06 October 2021

*Special Populations*
Effects of Renal Impairment on the Pharmacokinetics of Abrocitinib and Its Metabolites
Ellen Q. Wang PhD, Vu Le MS, Jennifer A. Winton MS, Sakambari Tripathy MS, Sangeeta Raje PhD, Lisy Wang MD, Martin E. Dowty PhD, Bimal K. Malhotra PhD
Pages: 505-519 | First Published: 12 October 2021

Pharmacokinetics of Tropifexor, a Potent Farnesoid X Receptor Agonist, in Participants With Varying Degrees of Hepatic Impairment
Jin Chen PhD, Jessie Gu PhD, Bharti Shah PhD, Rowan Stringer PhD, Leonel Reis da Silva Torrao MSc, Melissa Hackling BSc, Prasanna Kumar Nidamarthy MSc, William T. Prince FFPM, Ralph Woessner PhD
Pages: 520-531 | First Published: 04 November 2021

*Pharmacokinetics*
Pharmacokinetic Simulation Analysis of Less Frequent Nivolumab and Pembrolizumab Dosing: Pharmacoeconomic Rationale for Dose Deescalation
Cody J. Peer PhD, Brian L. Heiss MD, Daniel A. Goldstein MD, Jennifer C. Goodell BS, William D. Figg PharmD, FCP, Mark J. Ratain MD, FCP
Pages: 532-540 | First Published: 14 October 2021

*Modeling and Simulation*
Predicted Cardiac Functional Responses to Renal Actions of SGLT2i in the DAPACARD Trial Population: A Mathematical Modeling Analysis
Hongtao Yu PhD, Sanchita Basu MS, Weifeng Tang PhD, Robert C. Penland PhD, Peter J. Greasley PhD, Jan Oscarsson PhD, David W. Boulton PhD, K. Melissa Hallow PhD
Pages: 541-554 | First Published: 17 October 2021

*Pharmacometrics*
Population Pharmacokinetics of Ponatinib in Healthy Adult Volunteers and Patients With Hematologic Malignancies and Model‐Informed Dose Selection for Pediatric Development
Michael J. Hanley PharmD, PhD, Paul M. Diderichsen PhD, Narayana Narasimhan PhD, Shouryadeep Srivastava MBBS, PhD, Neeraj Gupta PhD, Karthik Venkatakrishnan PhD
Pages: 555-567 | First Published: 26 October 2021

*Letter to the Editor*
Clearance of Lormetazepam, Midazolam, and Their Conjugated Metabolites by Continuous Venovenous Hemofiltration During Prolonged Sedation in Critically Ill Patients With COVID‐19‐Associated Acute Respiratory Distress Syndrome
Kimberly N. Shudofsky PharmD, Paddy K. C. Janssen PhD, Norbert Foudraine MD, PhD, Jos L. M. L. le Noble MD, PhD
Pages: 568-570 | First Published: 18 November 2021

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High-quality CME & CPE live, webinar and enduring events; The Journal of Clinical Pharmacology and Clinical Pharmacology in Drug Development

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21750 Red Rum Dr, Ste 137
Ashburn, VA
20147

General information

ACCP is a member-driven/member-focused organization that provides accredited continuing education to healthcare professionals. ACCP also publishes The Journal of Clinical Pharmacology and will soon publish the eJournal Clinical Pharmacology in Drug Development.

Opening Hours

Monday 8am - 5pm
Tuesday 8am - 5pm
Wednesday 8am - 5pm
Thursday 8am - 5pm
Friday 8am - 5pm

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