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Study design. This was a double-blind, crossover randomized controlled trial. Patients were randomized to receive either methotrexate (MTX) or placebo (PBO) during an initial treatment period of three months, followed by a ‘wash-out’ phase of two months and a crossover second treatment period of three months. The T + X (↓) represent monthly assessments since randomization; the status (↑) represent medical visits with a clinical examination.
