Clinical trial • Phase II • Oncology|Rare Disease

momelotinib dihydrochloride monohydrate for Myelodysplastic syndrome|Low-risk myelodysplastic syndrome

Phase II trial of momelotinib dihydrochloride monohydrate for Myelodysplastic syndrome|Low-risk myelodysplastic syndrome.

Overview

Trial Therapeutic Area
Oncology|Rare Disease
Trial Disease
Myelodysplastic syndrome|Low-risk myelodysplastic syndrome
Trial Stage
Phase II
Drug Modality
Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
10-04-2025
First CTIS Authorization Date
06-08-2025

Trial design

Randomised, open-label, arm 1: mmb dose level 1 po qd; arm 2: mmb dose level 2 po qd-controlled, adaptive Phase II trial in Italy, France, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Arm 1: MMB Dose level 1 PO QD; Arm 2: MMB Dose level 2 PO QD
Adaptive
True, Part 1 is to identify the RP2D with two dose levels (Dose level 1 and Dose level 2) and Part 2 assigns participants to the RP2D; dose-finding/adaptive element to determine RP2D across Part 1 and Part 2.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
35
Trial Duration For Participant
168

Eligibility

Recruits 35 No vulnerable population selected (populationOfTrialSubjects.isVulnerablePopulationSelected = false). Participants must be capable of giving signed informed consent as described in Section 10.1; consent is provided by the participant. No assent process for minors is specified (minimum age ≥18 or legal age of consent)..

Pregnancy Exclusion
5. A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: a. Is a woman of non-childbearing potential (WONCBP) (as defined in Section 10.4), OR b. Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency (as described in Section 10.4) 28 days prior to and during the study intervention period and for at least 1 week after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.
Vulnerable Population
No vulnerable population selected (populationOfTrialSubjects.isVulnerablePopulationSelected = false). Participants must be capable of giving signed informed consent as described in Section 10.1; consent is provided by the participant. No assent process for minors is specified (minimum age ≥18 or legal age of consent).

Inclusion criteria

  • {"criterion_text":"- Participants are eligible to be included in the study only if all of the following criteria apply. 1. Age ≥18 years OR of legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the ICF."}
  • {"criterion_text":"- 2. Documented diagnosis of MDS according to the World Health Organization classifications [Arber, 2016] with an IPSS-R classification of very low, low, or intermediate risk disease, with an overall risk score ≤3.5 [Greenberg, 2012]."}
  • {"criterion_text":"- 3. Received ESA OR luspatercept and/or other therapies approved by health authorities and available for the treatment of LR-MDS-related anemia that is relapsed/refractory or intolerant to the most recent therapy prior to screening. −Relapse/Refractory to most recent prior treatment: documentation of loss of erythroid (E) response or never achieved hematologic improvement (HI-E) response as defined by the IWG 2018 criteria [Platzbecker, 2019]. If the most recent prior treatment is ESA or Luspatercept."}
  • {"criterion_text":"- 4. Red blood cell transfusion dependence, defined as requiring an average of ≥4 units of pRBC transfused over an 8-week period during the 16 weeks preceding randomization. Documentation of a participant’s transfusion policy during this 16week period is required."}
  • {"criterion_text":"- 5. A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: a. Is a woman of non-childbearing potential (WONCBP) (as defined in Section 10.4), OR b. Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency (as described in Section 10.4) 28 days prior to and during the study intervention period and for at least 1 week after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention."}
  • {"criterion_text":"- 6. Is capable of giving signed informed consent as described in Section 10.1, including compliance with the requirements and restrictions listed in the ICF and in this protocol."}
  • {"criterion_text":"- 7. Eastern Cooperative Oncology Group performance status ≤2 (see Section 10.7)"}
  • {"criterion_text":"- 8. Adequate organ function as defined in Table 8."}

Exclusion criteria

  • {"criterion_text":"- Participants are excluded from the study if any of the following criteria apply. 1. Prior treatment with the following at any time: a. Hypomethylating agents or other disease modifying agents (i.e., IMiDs) and immunosuppressive therapy for MDS Note: Exception to this exclusion is if ≤1 week of treatment received; provided last dose was ≥8 weeks from randomization"}
  • {"criterion_text":"- 10. Diagnosis of invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years, except as noted below: a. History of an invasive malignancy for which the participant was definitively treated, and in which the participant has been disease free for at least 2 years, and which, in the opinion of the principal investigator and medical monitor, is not expected to affect the evaluation of the effects of the study intervention on the currently targeted disease under study b. Curatively treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, and/or in situ breast cancer may be enrolled c. Incidental histologic finding of prostate cancer (T1a or T1b using the TNM clinical staging system)"}
  • {"criterion_text":"- 11. Uncontrolled intercurrent illness including, but not limited to: a. Active uncontrolled infection (participants receiving outpatient antibacterial and/or antiviral treatments for infection that is under control or as infection prophylaxis may be included in the trial); or b. Significant active or chronic bleeding event ≥Grade 2 per CTCAE v5.0 within 4 weeks prior randomization c. Uncontrolled acute and chronic liver disease (e.g., Child-Pugh score ≥10) OR has current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. NOTE: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) is acceptable if participant otherwise meets entry criteria"}
  • {"criterion_text":"- 12. Any of the following conditions within 6 months prior to randomization: a. Unstable angina pectoris b. Symptomatic congestive heart failure c. Uncontrolled cardiac arrhythmia"}
  • {"criterion_text":"- 13. QTc interval >480 msec (corrected using Fridericia formula)."}
  • {"criterion_text":"- 14. Psychiatric illness, social situation, or any other condition that would limit compliance with trial requirements or may interfere with the interpretation of study results, as judged by investigator or sponsor."}
  • {"criterion_text":"- 15. Presence of peripheral neuropathy ≥Grade 2 per CTCAE v5.0."}
  • {"criterion_text":"- 16. Known positive status for HIV."}
  • {"criterion_text":"- 17. Hepatitis A, B, or C status as defined below: a. Chronic active or acute viral hepatitis A. b. Active Hepatitis B infection indicated by the presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to the first dose of study intervention. c. Positive hepatitis C antibody test result at screening or within 3 months before the first dose of study intervention. NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative hepatitis C RNA test is obtained."}
  • {"criterion_text":"- 18. Has any clinically significant gastrointestinal conditions or abnormalities that may alter absorption, e.g., uncontrolled nausea, vomiting, malabsorption syndrome or major resection of the stomach and/or bowels."}
  • {"criterion_text":"- 19. Is unable to swallow and/or retain oral medications"}
  • {"criterion_text":"- 2. Use of the following treatments within the noted time periods referenced from date of randomization: a. ESA within 4 weeks, or 8 weeks for long-acting ESA b. Growth factors (i.e., G-CSF, GM-CSF) within 4 weeks c. Luspatercept within 8 weeks d. Imetelstat within 8 weeks e. Investigational agents within 4 weeks or 5 half-lives, whichever is longer f. Corticosteroids for treatment of the underlying disease within 28 days. Supportive care use of steroids for non-MDS indications may be used provided participant is on a stable dose equivalent to ≤10 mg prednisone per day g. Other active anti-MDS therapy not otherwise listed within 28 days or 5 halflives whichever is longer h. Potent cytochrome P450 3A4 (CYP3A4) inducers, except for rifampin and rifampicin, within 14 days prior to the first dose of momelotinib i. Has received a live vaccine within 30 days"}
  • {"criterion_text":"- 20. Known contraindication or hypersensitivity to momelotinib and its metabolites, or any of their excipients."}
  • {"criterion_text":"- 3. Prior allogeneic or autologous stem cell transplant"}
  • {"criterion_text":"- 4. Has had any major surgery within 28 days prior to randomization"}
  • {"criterion_text":"- 5. Ongoing adverse reaction(s) from prior therapy that have not recovered to ≤Grade 1 or to the baseline status preceding prior therapy, except if the investigator, with the agreement of the sponsor, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study."}
  • {"criterion_text":"- 6. MDS associated with del 5q cytogenetic abnormality"}
  • {"criterion_text":"- 7. Secondary MDS (i.e., MDS that is known to have arisen as the result of chemical injury, treatment with chemotherapy, and/or radiation for other diseases)."}
  • {"criterion_text":"- 8. Known history of diagnosis of acute myeloid leukemia."}
  • {"criterion_text":"- 9. Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, gastrointestinal bleeding, or thalassemia."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Percentage of participants with RBC-TI (rolling 12 weeks)","definition_or_measurement_approach":"RBC-TI measured as independence from red blood cell transfusions over a rolling 12-week period (percentage of participants achieving RBC-TI)."}
  • {"endpoint_text":"- 2. Selected safety endpoints: Grade >= 3 AE, AEs leading to treatment discontinuation and/or dose modifications","definition_or_measurement_approach":"Safety measured by incidence of Grade ≥3 adverse events, adverse events leading to treatment discontinuation and/or dose modifications."}
  • {"endpoint_text":"- 3. Pharmacokinetic parameters of momelotinib and M21 (e.g., Cmax, AUC), as data permit","definition_or_measurement_approach":"PK parameters including Cmax and AUC for momelotinib and metabolite M21 as data permit."}

Secondary endpoints

  • {"endpoint_text":"- 1. Percentage of participants with ≥12 weeks of RBC-TI by the end of Week 24","definition_or_measurement_approach":"Proportion of participants with at least 12 consecutive weeks of RBC-TI assessed by end of Week 24."}
  • {"endpoint_text":"- 2. Incidence and severity of AEs and SAEs, and AEs leading to treatment discontinuation or dose modifications by the end of Week 24 and longer term","definition_or_measurement_approach":"Incidence and severity (grading) of AEs and SAEs and events causing discontinuation or dose modification assessed at Week 24 and longer term."}
  • {"endpoint_text":"- 3. Clinically important changes in laboratory parameters and vital signs by the end of Week 24 and longer term","definition_or_measurement_approach":"Clinically important laboratory and vital sign changes monitored and summarized by Week 24 and over longer follow-up."}
  • {"endpoint_text":"- 4. Plasma concentration of momelotinib and M21","definition_or_measurement_approach":"Measurement of plasma concentrations of momelotinib and M21."}

Recruitment

Registry Or Advocacy Recruitment
True, Europese Organisatie Voor Onderzoek En Behandeling Van Kanker (EORTC) is listed as a third-party patient organisation; FACIT.Org Inc. is also listed (patient/PRO organisation).
Digital Remote Recruitment
True, vendors listed include Medable Inc. (responsible for eCOA) and Synexus Clinical Research Limited (provision of home nurses and home visit services), indicating use of electronic patient-reported outcomes and home/remote services.
Planned Sample Size
35
Recruitment Window Months
39
Consent Approach
Signed informed consent must be provided by the participant (inclusion criterion: 'Is capable of giving signed informed consent as described in Section 10.1'). Subject information and ICF documents are provided country-specifically; main ICFs and optional/additional ICFs exist in multiple languages (Italian, French, German, Spanish, Polish, English) and include optional genetic research ICFs and pregnancy-related ICFs. No assent for minors is specified (minimum age ≥18 or legal age of consent).

Methods

  • K1 Recruitment arrangements and informed-consent procedure documents present for Italy, France, Germany, Spain, Poland (document titles indicate use of country-specific recruitment arrangements and doctor/GP letters).
  • Doctor-to-Doctor letters (country-specific K2 documents: Italy, Poland) — channel: direct clinician-to-clinician communication to identify eligible patients.
  • GP/Doctor letters (e.g., GP-Letter_ES_Public) — channel: letters to general practitioners to refer eligible patients (Spain).
  • Country-specific Recruitment-Arrangements documents (France, Germany, Italy, Spain, Poland) — channel and target audience implied by document titles; country-specific procedures for recruitment and informed consent.

Geography

Total Number Of Sites
29
Total Number Of Participants
56

Italy

Earliest CTIS Part Ii Submission Date
24-07-2025
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
265
Number Of Sites
6
Number Of Participants
11

Sites

Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
SCUD Medicina Interna ad indirizzo Ematologico
Contact Person Name
Marco De Gobbi
Contact Person Email
marco.degobbi@unito.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Area Medica - S.C. Ematologia
Contact Person Name
Bruno Fattizzo
Site Name
Humanitas Mirasole S.p.A.
Department Name
Oncology and Hematology
Contact Person Name
Matteo Giovanni Della Porta
Contact Person Email
matteo.della_porta@hunimed.eu
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
SOC Clinica ematologica
Contact Person Name
Mario Tiribelli
Contact Person Email
mario.tiribelli@uniud.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Department of Experimental and Clinical Medicine
Contact Person Name
Valeria Santini
Contact Person Email
dmsc@pec.unifi.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Hematology
Contact Person Name
Giuseppe Alberto Maria Palumbo
Contact Person Email
palumbo.ga@gmail.com

France

Earliest CTIS Part Ii Submission Date
24-07-2025
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
263
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Centre Hospitalier Le Mans
Department Name
Centre de Cancérologie de la Sarthe
Contact Person Name
Kamel Laribi
Contact Person Email
klaribi@ch-lemans.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
IUCT-O
Contact Person Name
Thibault Comont
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Department (DMU) of hematology and immunology
Contact Person Name
Pierre Fenaux
Contact Person Email
pierre.fenaux@aphp.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Hematological oncology and cellular therapy
Contact Person Name
Jose Miguel Torregrosa-Diaz
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Hematology Department
Contact Person Name
Thomas Cluzeau
Contact Person Email
cluzeau.t@chu-nice.fr

Germany

Earliest CTIS Part Ii Submission Date
10-07-2025
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
278
Number Of Sites
6
Number Of Participants
5

Sites

Site Name
Universitaet Muenster
Department Name
Medizinische Klinik Hämatologie / Onkologie
Contact Person Name
Jan-Henrik Mikesch
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Hämatologie und Onkologie
Contact Person Name
Niklas Gebauer
Contact Person Email
niklas.gebauer@uksh.de
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie
Contact Person Name
Madlen Jentzsch
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
III. Medizinische Klinik und Poliklinik Hämatologie und Medizinische Onkologie
Contact Person Name
Daniel Sasca
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I
Contact Person Name
Ekaterina Balaian
Contact Person Email
ekaterina.balaian@ukdd.de
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Klinik und Poliklinik für Innere Medizin III
Contact Person Name
Katharina Götze
Contact Person Email
katharina.goetze@tum.de

Spain

Earliest CTIS Part Ii Submission Date
30-07-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
261
Number Of Sites
9
Number Of Participants
13

Sites

Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Hematology & Hemotherapy
Contact Person Name
Regina García-Delgado
Contact Person Email
reginagarciadel@yahoo.es
Site Name
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Hematology
Contact Person Name
Montserrat Arnan
Contact Person Email
marnan@iconcologia.net
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Hematology
Contact Person Name
Ana Alfonso
Contact Person Email
aalfonso@unav.es
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Contact Person Name
María Diez Campelo
Contact Person Email
mdiezcampelo@usal.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Hematology
Contact Person Name
Maria del Mar Tormo Diaz
Contact Person Email
tormo_mar@gva.es
Site Name
Complejo Hospitalario Universitario De Ourense
Department Name
Hematology
Contact Person Name
Jose Luis Sastre Moral
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Hematology
Contact Person Name
Blanca Xicoy
Contact Person Email
bxicoy@iconcologia.net
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Contact Person Name
David Valcarcel
Contact Person Email
dvalcarcel@vhio.net
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Hematology
Contact Person Name
Ana Alfonso
Contact Person Email
aalfonso@unav.es

Poland

Earliest CTIS Part Ii Submission Date
29-07-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
265
Number Of Sites
3
Number Of Participants
2

Sites

Site Name
Mtz Clinical Research Powered By Pratia
Contact Person Name
Krzysztof Mądry
Contact Person Email
badacz@pratia.com
Site Name
Pratia Hematologia Sp. z o.o.
Department Name
Pratia Onkologia Katowice
Contact Person Name
Sebastian Grosicki
Contact Person Email
sgrosicki@wp.pl
Site Name
Wojewodzki Szpital Specjalistyczny W Legnicy
Department Name
Oddział Hematologii
Contact Person Name
Jadwiga Hołojda

Sponsor

Primary sponsor

Full Name
Glaxosmithkline Research & Development Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Contract research organisations

Name
PPD Global Limited
Responsibilities
Multiple operational sponsor duties (codes: ["1","10","12","13","2","5","6","7","8"]), contact email: EUCTRInquiry.sm@ppd.com
Name
PPD Development LP
Responsibilities
Sponsor duties (code: "4"), contact email: RichmondSMOpeners@ppd.com
Name
PPD Global Central Labs
Responsibilities
Central laboratory services (sponsorDuties code: "4"), contact email: Lorraine.McNamara@ppd.com
Name
Frontage Laboratories Inc.
Responsibilities
Laboratory services (sponsorDuties code: "4"), contact email: BioA-PIGroup@frontagelab.com
Name
Synexus Clinical Research Limited
Responsibilities
Provision of home nurses and home visit services (sponsorDuties code: "15"), contact email: hometrialservices.sm@ppd.com

Third parties

  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties codes: [\"4\"], contact email: Lorraine.McNamara@ppd.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"sponsorDuties codes: [\"1\",\"10\",\"12\",\"13\",\"2\",\"5\",\"6\",\"7\",\"8\"], contact email: EUCTRInquiry.sm@ppd.com","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi","duties_or_roles":"sponsorDuties codes: [\"6\"], contact email: qol.services@eortc.org","organisation_type":"Patient organisation/association"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"sponsorDuties codes: [\"15\"], value: Long-term storage, contact email: Operations.GRI@Azenta.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: [\"4\"], contact email: RichmondSMOpeners@ppd.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"FACIT.Org Inc.","duties_or_roles":"sponsorDuties codes: [\"6\"], contact email: information@facit.org","organisation_type":"Hospital/Clinic/Other health care facility (listed as organisation type in record)"}
  • {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"sponsorDuties codes: [\"4\"], contact email: Disha.patel@sampled.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"sponsorDuties codes: [\"15\"], value: eCOA, contact email: nancy.annunziato@medable.com","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [\"4\"], contact email: BioA-PIGroup@frontagelab.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Synexus Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [\"15\"], value: The provision of home nurses to attend patients homes and perform tasks and activities as delegated by the site/PI, contact email: hometrialservices.sm@ppd.com","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [\"4\"], contact email: Pharma_Project_Support_Team@neogenomics.com","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"sponsorDuties codes: [\"15\"], value: Participant Compensation and Participant Travel Services, contact email: clientcompliance@meetingprotocol.com","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Momelotinib (tablets; sponsor product code GSK3070785)
Active Substance
momelotinib dihydrochloride monohydrate
Modality
Small molecule
Routes Of Administration
Oral use (tablet)
Route
Oral
Authorisation Status
Investigational medicinal product (IMP12407/00001) - not marketed (as IMP in trial)
Orphan Designation
Yes
Dose Levels
Dose level 1; Dose level 2
Frequency
Once daily (QD)
Dose Escalation Increase
Dose level 1 and Dose level 2 (specific mg/dose not specified in provided data)

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