Table 2 Additional inclusion and exclusion criteria for patients in Group C

1.

Bone marrow reserve adequate for chemotherapy (i.e. absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/l and platelet count ≥ 100 × 10⁹/l)

2.

Adequate creatinine clearance defined as GFR ≥ 50 ml/min

1.

History of significant cardiac or other medical conditions that preclude the use of cisplatin and intravenous hydration

2.

Clinically significant hearing impairment sufficient to affect daily living and/or pre-existing tinnitus

3.

Pre-existing peripheral neuropathy that precludes the use of cisplatin

4.

Hypersensitivity to the active substance or other platinum compounds or to any of the other excipients

5.

Dehydrated condition