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Wu et al

Therefore, evidence of similarity did not result in FDA approval of temozolomide.[43][Level of evidence A1] An extended schedule and escalated dose of temozolomide was compared with dacarbazine in a multicenter trial by the European Organisation for Research and Treatment of Cancer (EORTC) (EORTC-18032 [NCT00101218]) that randomly assigned 859 patients

Patients were randomized (sequential series of 4 per block, sealed envelopes, computer generated randomization code) to receive either an oral liquid formulation of L-Carnitine (4 g/d, obtained from Lonza, Basel, CH) or identically formulated placebo with follow up visits at 6 and 12 weeks after entry

This estimate, along with the lowest bound of decline (12%) meets the threshold for Vulnerable (C1), following a precautionary principle

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