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Fig 1.

Flow chart of patient disposition.

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Table 1.

Demographic and baseline patient characteristics.

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Fig 2.

Efficacy outcome: Analysis of 100-mm pain VAS.

A. Efficacy outcome: analysis of 100-mm pain VAS at week 2, 4 _ change of 100mm Pain VAS (PP). B. Efficacy outcome: analysis of 100-mm pain VAS at week 2, 4 _ change of 100mm Pain VAS (FA).

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Table 2.

Primary efficacy outcome: Analysis of 100-mm pain VAS at week 4 (PP and FA sets).

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Table 2 Expand

Table 3.

Primary efficacy outcome: analysis (adding site factor) of 100-mm pain VAS at week 4 (PP and FA sets).

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Table 4.

Analyses of secondary efficacy outcomes (PP set): 100-mm pain VAS at week 2 and K-WOMAC scores.

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Table 5.

Analyses of secondary efficacy outcomes (FA set): 100-mm pain VAS at week 2 and K-WOMAC scores.

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Table 6.

Secondary efficacy outcomes: patient global assessment and use of rescue medicine (PP and FA sets).

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Table 7.

Adverse events during the study (safety set).

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