Inclusion Criteria:

- Low or intermediate-1 risk MDS patients per IPSS at the time of randomisation, as
determined by complete blood count (CBC) during screening and bone marrow examination
and marrow cytogenetic analysis performed within 16 weeks prior to randomisation.
Subject cannot have been rendered low or intermediate-1 risk by prior disease
modifying therapy. Bone marrow slides must be available for centralised review at any
time throughout the study

- World Health Organization (WHO) classification of refractory anaemia (RA), refractory
anaemia with ring sideroblasts (RARS), refractory cytopenias with multilineage
dysplasia (RCMD), MDS-unclassified (MDSU), MDS with isolated del(5q) (5q- syndrome)
or refractory anaemia with excess blasts-1 (RAEB-1)

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 assessed
during screening

- Haemoglobin level ≤ 10.0 g/dL as assessed by the local laboratory; sample obtained
within 7 days prior to randomisation (retest during screening is acceptable)

- Adequate transferrin saturation (Tsat) (≥ 15%) and serum ferritin (≥ 10 ng/mL) as
assessed by the central laboratory during screening (supplementation and retest
during screening is acceptable)

- Adequate serum folate (≥ 4.5 nmol/L [≥ 2.0 ng/mL]) or RBC folate (≥ 317 nmol/L [≥ 140
ng/mL]) as assessed by the local laboratory during screening (supplementation and
retest during screening is acceptable)

- Adequate vitamin B12 (≥ 148 pmol/L [≥ 200 pg/mL]) as assessed by the local laboratory
during screening (supplementation and retest during screening is acceptable)

- 18 years of age or older

- Subject or subject's legally acceptable representative has provided informed consent
-

Exclusion Criteria:

- Previously diagnosed with intermediate-2 or high risk MDS per International
Prognostic Scoring System (IPSS)

- Therapy-related or secondary MDS

- History of acute leukemia

- Evidence of bone marrow collagen fibrosis

- Inherited anaemia (eg, haemoglobinopathy, thalassemia, red cell membrane defect, red
cell enzyme deficiency), active hemorrhage, red cell aplasia, haemolytic anaemia

- History of malignancies other than curatively treated non-melanoma skin or in situ
carcinoma

- History of thrombosis within 6 months prior to randomisation

- Previous bone marrow or stem cell transplantation

- Uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia
as determined by the investigator at screening. Subjects with known myocardial
infarction within 6 months prior to randomisation

- Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg and/or
diastolic blood pressure ≥ 100 mmHg at screening

- Clinically significant systemic infection or uncontrolled chronic inflammatory
disease (ie, rheumatoid arthritis, inflammatory bowel disease) as determined by the
investigator at screening

- History of seizure disorder (subject with previous history of seizure disorder will
be eligible for the study if he/she had no evidence of seizure activity within 5
years of randomisation and is currently free of antiseizure medication)

- Previous or ongoing use of ESA therapy, eg, rHuEpo, darbepoetin alfa

- High transfusion demand: receiving a total of ≥ 4 units of RBC transfusion during
either of 2 consecutive 8-week periods (ie, days -113 to -57 or days -56 to 0) prior
to randomisation

- Received any RBC transfusion within 14 days prior to randomisation

- Received cytotoxic chemotherapy for any oncologic indication or planning to receive
cytotoxic chemotherapy during the double-blind treatment period of the study

- Received biologic response modifiers (eg, thalidomide, lenalidomide, arsenic
trioxide, azacitidine, decitabine) to treat MDS or planning to receive biologic
response modifiers during the double-blind treatment period of the study

- Received myeloablative or craniospinal radiation or planning to receive myeloablative
or craniospinal radiation during the double-blind treatment period of the study

- Received G-CSF therapy within 30 days prior to randomisation or planning to receive
G-CSF therapy during the double-blind treatment period of the study (temporary use of
G-CSF for neutropenia with fever and/or infection is acceptable)

- Abnormal renal function (serum creatinine level > 2 times the upper limit of the
respective normal range [ULN]) as assessed by the central laboratory at screening

- Abnormal liver function (total bilirubin > 2 times, alanine aminotransferase [ALT] or
aspartate aminotransferase [AST] > 3 times ULN) as assessed by the central laboratory
at screening. (Subjects with abnormal bilirubin at screening due to documented
Gilbert's Disease are eligible if all other criteria are met.)

- Serum endogenous erythropoetin (EPO) level > 500 mU/mL as assessed by the central
laboratory at screening

- Known seropositivity for human immunodeficiency virus (HIV) or diagnosis of Acquired
Immunodeficiency Syndrome (AIDS), positive for hepatitis B surface antigen, or
seropositive for hepatitis C virus

- Subjects with active ethanol abuse, as judged by the investigator

- Currently enrolled in another investigational device or drug study, or less than 30
days since ending another investigational device or drug study(s), or receiving other
investigational agent(s)

- Female subject is not willing to use highly effective contraception during treatment
and for at least 1 month after the end of treatment

- Female subject is pregnant or planning to become pregnant within 1 month after the
end of treatment

- Subject has known sensitivity to any of the products to be administered during dosing

- Subject has previously been randomised into this study

- Subject will not be available for protocol-required study visits, to the best of the
subject and investigator's knowledge

- Subject has any kind of disorder that, in the opinion of the investigator, may
compromise the ability of the subject to give written informed consent and/or to
comply with all required study procedures

- Confirmed history of neutralising antibody activity to rHuEpo or darbepoetin alfa