Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years

Inclusion Criteria:

1. Patient is willing and able to comply with the study requirements and to providewritten informed consent. In the case of patients under the age of legal consent,the legal guardian(s) must provide informed consent and the patient should provideassent per local and national requirements.

2. Age ≥1 month and ≤17 years at the time of informed consent

3. Subjects must have iron deficiency anaemia defined by the following criteria, asmeasured by the central laboratory at the screening visit

Haemoglobin thresholds define anaemia by age and gender:

Children (1 m - < 5 yrs) <11.0 g/dl Children (5 yrs - < 12 yrs) <11.5 g/dl Children (12 yrs) <12.0 g/dl Female child (≥13 yrs) <12.0 g/dl Male child (≥13 yrs) <13.0 g/dl and

Ferritin thresholds define anaemia by:

ferritin <30 µg/L, or ferritin <50 µg/L with transferrin saturation (TSAT) <20%, 4. Female subjects of childbearing potential must agree to use a highly effective method of contraception (which includes complete abstinence) until study completion and for at least 4 weeks following their final study visit. Highly effective contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), a vasectomised partner and oral contraceptive medications.

The need for contraception and compliance with contraception requirements will be assessed at every visit for adolescent patients, and urine pregnancy testing will be performed at each visit for female subjects of childbearing potential.

Exclusion Criteria:

1. Subject with anaemia due to any cause other than iron deficiency, including, but notlimited to, a. Untreated or untreatable severe malabsorption syndrome

2. Subjects who have received prior to Screening:

3. Within 28 days intramuscular or intravenous (IV) injection or administration ofdepot iron preparation.

4. Within 7 days single agent iron preparations and during the study.

5. Within 12 weeks of blood transfusion or is scheduled to have blood transfusionor donation during the study period

6. Within 28 days erythropoiesis stimulating agents and during the study period

7. Within 14 days COVID-19 vaccination

8. Subjects with vitamin B12 or folic acid deficiency as determined by the centrallaboratory screening results. Subjects may start vitamin B12 or folate replacementand rescreen after at least 2 weeks.

9. Has concomitant disease that would significantly compromise iron absorption orabsorbed iron utilization such as swallowing disorders and/or extensive small bowelresection.

10. History of active peptic ulcer

11. Has chronic renal disease (eGFR <60 mL/min/m2), as assessed at Screening based onserum creatinine.

12. Known hypersensitivity or allergy to either the active substance or excipients offerric maltol or ferrous sulfate.

13. Has a known contraindication for treatment with iron preparations, e.g.haemochromatosis, chronic haemolytic disease, sideroblastic anaemia, thalassemia, orlead intoxication induced anaemia.

14. Impaired liver function as indicated by alanine aminotransferase (ALT) or aspartatetransaminase (AST)>2.0 times upper normal limit as measured at the Screening visit.

15. Active acute inflammatory disease, including IBD flare or disease exacerbation,which in the opinion of the Investigator, is clinically significant.

16. Active chronic or acute infectious diseases requiring antibiotic treatment.

17. Pregnant or breast feeding.

18. Concomitant medical conditions with extensive active bleeding, other than menstrualcycles; subjects who suffer from menorrhagia may be included at the Investigator'sdiscretion.

19. Scheduled or expected hospitalisation and/or surgery during the course of the study

20. Participation in any other interventional clinical study within 28 days prior toScreening.

21. Diagnosed to be COVID-19 positive by (SARS-CoV-2-RT-PCR positive) within 28 daysprior to screening.

22. Cardiovascular, liver, renal, hematologic, psychiatric, neurologic,gastrointestinal, immunologic, endocrine, metabolic, respiratory or central nervoussystem disease that, in the opinion of the Investigator, may adversely affect thesafety of the subject and/or objectives of the study drug or severely limit thelifespan of the subject.

23. Any other unspecified reason that, in the opinion of the Investigator or the Sponsormake the subject unsuitable for enrolment.