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A minimum follow-up of 12 months was planned.
In accordance with the consultant urologist, periodic follow up – every 3 or 6 months – was planned for patients with lesions not suspicious for malignancy.
Levamisole 50 mg p.o. t.i.d. on days 1 3, every 14 days for 6 months, was planned to be given in both arms.
An original sample size of 600 subjects, enrolled over 24 months, was planned in order to detect a one-point between-treatment group difference on change from baseline to week 4 in Tsui total score with 90% power.
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Alendronate, risedronate, zoledronic acid, and denosumab are approved for the prevention of fractures during chronic treatment with glucocorticoids or when chronic treatment with glucocorticoids lasting more than 3 months is planned (prednisone equivalent dose ≥ 5 mg/day) (grade A recommendation).
The slogan on the front of the package states: "Protein and peanuts in a filling chocolate bar" (ブチプロテイン&ピーナッツin満足系チョコバー). A limited run of twelve months is planned for the Morning Thunder bar.
Continued follow up to 36 months is planned.
Twelve months are planned for the systemic intervention.
A patient accrual period of 24 months and a follow-up period of 12 months were planned.
Accordingly, 55 patients for each arm and their accrual period of 24 months were planned for this study.
Active and systematic follow-up of all randomised participants at 3, 6, 12 and 24 months is planned.
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