Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS

Summary of the actual values of IRLS total score on baseline and Day 42, and the change from baseline to Day 42. Eligible subjects were to have met the following requirements prior to receiving additional treatment: A baseline score ≥ 15 on the International Restless Legs Syndrome (IRLS) Rating Scale. The minimum score is 15 with the maximum of 40. A score of less than 15 is not an indicator of RLS. However, a score of 15 or greater is an indicator of RLS. Further increase indicates more severe disease.

Time frame: Baseline and Day 42

Population: One subject did not receive study drug and was excluded from the safety and Full analysis set population.

Responder is defined as subjects rated as much or very much improved with the CGI-I on Day 42. Summary of the number (percentage) of CGI-I responder. Per the protocol, the he CGI is a 3-item observer-rated scale that measures illness severity (CGIS), global improvement or change (CGIC) and therapeutic response. The scale requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.

Time frame: Day 42

Population: Responder(a), n/m(b) : a : Responder was defined as subjects rated as much or very much improved with the CGI-I.~b : n is the number of responders; m is number of subjects who had non-missing results at the visit.

Similar to the CGI-I except this is self-reported, 7-item scale for assessment of symptoms after treatment with the rating as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.

Time frame: Day 42

Population: Observed cases (n/m(a) \[%\])~a: n is the number of subjects of the category, m is number of subjects who have non-missing results at the visit.

The Fatigue Linear Analog Scale is a self-assessment scale in which a 100 mm line is used to measure the severity of fatigue and its effect on a person's activities and lifestyle. The scale severity measure ranges from No Fatigue to Worst Possible Fatigue.

Time frame: Baseline and Day 42

Population: One subject did not receive study drug and was excluded from the Safety and Full Analysis Set Populations.

The MOS-Sleep scale, is a 12-item standardized, validated questionnaire for assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache which has been demonstrated to be sensitive to RLS treatment effects. This questionnaire provides information about sleep quality. Individual questions can be used for analysis but summary or index scores of a group of questions, is more commonly used in analysis. The quantity of sleep dimension is the average number of hours of sleep per night reported by the patient and the optimal sleep is a dichotomized version that is yes when the number of hours of sleep is 7 or 8. The scores of the dimensions and of the sleep problem index were converted to a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (e.g. greater sleep disturbance, greater adequacy of sleep).

Time frame: Change from Baseline and Day 42.

Population: Only participants with Sleep disturbance are included.

The Restless Legs Syndrome Quality of Life (RLS-QLI) instrument, a self-assessment, 17-item questionnaire with four scales identified through factor analysis: Daily Function, Social Function, Sleep Quality, and Emotional Well-Being, developed to facilitate clinical research on RLS. Scoring Instructions below: 1. Social Function = Sum (Items 1, 2, 3, 4), subtract 4, divide by 16, multiply by 100 2. Daily Function = Sum (Items 5, 6, 13,14, 15, 16), subtract 6, divide by 24, multiply by 100 3. Sleep Quality = Sum (Item 7, 8, 9, 17), subtract 4, divide by 18, multiply by 100 4. Emotional Well-being = Sum (Items 10, 11, 12), subtract 3, divide by 12, multiply by 100 Note: Resulting scores range between 0-100. Higher scores on the RLS-QLI indicate a lower quality of life. Lower scores indicate a higher quality of life.

Time frame: Baseline and Day 42

Population: One subject did not receive study drug and was excluded from the Safety and Full Analysis Set Populations.

Subjects could start tapering off pre-enrollment prescribed RLS medications after Day 5 until Day 365.

Time frame: Time from Day 5 to Day 365

Population: Full Analysis Set Population. Subjects who discontinued or completed the study before an intervention were censored at the last study visit.~Subjects Receiving RLS Intervention after Day 5.