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. 2018 Nov 15;7:1797. [Version 1] doi: 10.12688/f1000research.16786.1

Table 1. Full inclusion and exclusion criteria.

Inclusion criteria Exclusion criteria
Age 18 years or older. History of idiopathic seizure disorder, psychosis or schizophrenia.
A previous histopathologically verified diagnosis of glioblastoma/
gliosarcoma (later referred to as only glioblastoma) now presenting
with a first-time progression/recurrence documented by MRI.
Uncontrolled hypertension (i.e. systolic BP > 180 mmHg) and a
diagnosis of congestive heart failure
Planned treatment of recurrence with chemotherapeutic alkylating
agents
Received radiotherapy within the 3 months before the diagnosis
of tumor progression to reduce risk of misdiagnosis due to
pseudoprogression.
Karnofsky performance status of 60 – 100 22. Addiction to alcohol or drugs.
At inclusion not receiving another experimental treatment, including
compassionate use programs, for glioblastoma
Pregnant and/or breastfeeding and women of childbearing
potential who do not have a negative pregnancy test taken no
longer than 14 days prior to randomization.
Able to take oral medications. History of liver disease.
No known allergy to DSF or copper. History of Wilson's disease.
Absolute neutrophil count ≥ 1,500/mcL and platelets ≥ 100,000/mcL History of hemochromatosis.
Willingness to refrain from ingestion of alcoholic beverages while in
the study is a criterion to be randomized. However, once randomized
alcohol abstinence only affects the group treated with DSF
Nickel hypersensitivity 8
Need for metronidazole, warfarin and/or theophylline medication
since their metabolism may be influenced by DSF.
Patients who are taking medications metabolized by cytochrome
P450 2E1
Unfit for participation for any other reason judged by the
including physician