The most frequent adverse events were upper respiratory tract infection ( placebo @ -LSB- @ % -RSB- patients vs ALD@ @ -LSB- @ % -RSB- patients ) , urinary tract infection ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , fatigue ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , back pain ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , arthralgia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and nausea and vomiting ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .