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Concomitant psychotropic medications were permitted during the open-label phase as needed to treat an ongoing manic or hypomanic episode but were discontinued a minimum of 1 to 2 weeks before entry into the double-blind phase.
Patients who had received adjuvant chemotherapy completed 4 weeks before entry were eligible.
Patients who had received prior radiotherapy within the 2 weeks before entry into the trial were ineligible.
Previous anticancer radiotherapy or chemotherapy had to be discontinued for at least 4 weeks before entry into the study.
Previous chemotherapy and radiation therapy had to be discontinued for at least 4 weeks before entry into the study.
Only subjects with stable body weight, constant dietary habits and physical activity levels for at least four weeks before entry to the study were included.
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A bilateral maxillary sinusitis diagnosed a few weeks before was considered as the likely portal of entry.
Patients were not eligible in case of digital ulcers due to other conditions than SSc, prostanoid therapy during the last month, sympathectomy of the upper limb performed within 12 months before study entry, current smoking or smoking within 4 weeks before study entry, and any other severe concurrent illness.
Major exclusion criteria were: prior systemic chemotherapy (unless part of a multimodal treatment of locally advanced disease completed >6 months before study entry); prior EGFR-targeted therapy; surgery or irradiation ≤4 weeks before study entry; hormonal or other concomitant anticancer therapies; documented or symptomatic brain or leptomeningeal metastasis; and nasopharyngeal carcinoma.
Patients who were receiving antimalarial drugs, methotrexate, leflunomide, mycophenolate mofetil or azathioprine must have started them ≥3 months before study entry and the daily dose must have been stable during the 4 weeks before study entry.
The oldest, Nancy Moore Thurmond, was killed by a drunken driver in 1993, a month before her graduation from college and weeks before her entry into the Miss South Carolina pageant, where she had hoped to follow in her mother's footsteps.
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