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Subjects were assigned to treatment groups using a randomization number provided by Novartis Drug Supply Management using a validated computerized system (Almedica Drug Labeling System, Version 5.3 a, Almedica Technology Group Inc., Allendale, NJ, USA).
Patients were assigned to study treatment following a telephone call to the Registration and Medication Ordering System (RAMOS [GlaxoSmithKline, UK]) and randomized in accordance with a central randomization schedule generated by the sponsor using a validated computerized system (RandAll [GlaxoSmithKline, UK]).
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Plasma samples were analysed using a validated analytical method.
Toxicokinetics were determined using a validated dual-analyte bioanalytical method.
Psychological distress was measured using a validated five-item, short-version instrument, the SCL-5.
Resource use was measured using a validated questionnaire.
Serum neopterin was measured using a validated competition ELISA.
Serum olaratumab was quantitated by using a validated ELISA.
Clinical data were collected by using a validated questionnaire.
The samples were quantified using a validated HPLC method [ 11].
The drug concentrations were determined using a validated HPLC assay.
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